Drug Drug Interaction (DDI)Phase 1NCT07785934
Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity
A Phase 1 study testing UBT251, Metformin hydrochloride and Warfarin Sodium in people with Drug Drug Interaction (DDI) and Pharmacokinetics and Pharmacodynamics, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Drug Drug Interaction (DDI), Pharmacokinetics and Pharmacodynamics
- What is being tested?
- UBT251, Metformin hydrochloride and Warfarin Sodium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with overweight or obesity, aged 18-45 years inclusive; Cohort 1 includes male participants only, and Cohort 2 includes both male and female participants.
- Body weight ≥50.0 kg, body mass index (BMI) ranging from 24.0 to 35.0 kg/m² inclusive (BMI = weight(kg)/height²(m²)).
- Participants (including their partners) have no plan to conceive from screening through 6 months after study completion, are willing to adopt contraceptive measures specified in the study, and have no plan to donate sperm or ova within 6 months after trial completion.
- Participants are able to communicate well with investigators, have fully understood this study, voluntarily participate in it, understand and comply with all study requirements, and provide written informed consent.
Who cannot join
- Known hypersensitivity or intolerance to investigational product or its excipients, or hypersensitivity to other GLP-1, GIP, GCG receptor agonists; or prior history of multiple or severe clinically significant drug hypersensitivity reactions; or active allergic disease or high-sensitivity constitution;
- History or evidence of any of the following diseases:
- Personal or family history (first-degree relatives: parents, children or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- History of malignancy within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal-cell or squamous-cell skin cancer, radically resected local prostate cancer, and radically resected ductal carcinoma in situ of the breast;
- History of acute or chronic pancreatitis, pancreatic injury, or pancreatic surgery;
- History of acute cholecystitis, cholelithiasis or severe gallbladder polyps within 6 months prior to screening, for which the investigator assesses that study participation may increase the participant's risk;
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- History of dysphagia or any gastrointestinal disorder affecting drug absorption;
- Cardiovascular, respiratory, hepatic, gastrointestinal (including disorders markedly affecting gastric emptying or gastric motility, e.g. severe gastric spasm or pyloric stenosis), endocrine (including but not limited to history of thyroid carcinoma or preneoplastic lesions), hematological, neurological diseases, or muscular degenerative disorders that may significantly affect drug absorption, metabolism or elimination, increase participant risk, or confound data interpretation;
- History of severe hypoglycemic coma; or ≥3 episodes of blood glucose <3.9 mmol/L within any one week in the 2 months before screening (regardless of symptoms); or ≥1 episode of severe hypoglycemia per month within 2 months before screening (blood glucose <3.0 mmol/L accompanied by cognitive impairment or requiring third-party assistance);
- History of severe psychiatric disorders (including but not limited to suicidal ideation or suicide attempt, schizophrenia, bipolar disorder); or Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening;
- Severe infection, trauma or major surgical operation within 4 weeks prior to screening; or planned surgical procedure during the study;
- History of bariatric surgery for obesity;
- Use of dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1, GCG, GIP or amylin-targeted agents (e.g. exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, mazdutide, etc.) within 2 months before drug administration; or prior intolerance to the above-mentioned agents;
- Use of any medicinal products within 14 days or 5 half-lives (whichever is longer) prior to drug administration; and planned use of any medicinal products (prescription, over-the-counter, herbal medicines) and/or dietary supplements during the study;
- Abnormal findings with clinical significance as judged by the investigator in physical examination, vital signs, 12-lead electrocardiogram, or abdominal ultrasound at screening (mild-to-moderate fatty liver is excluded);
- Any clinically significant laboratory abnormality meeting any of the following criteria at screening:
- Hepatic impairment: serum ALT or AST >1.5 × upper limit of normal (ULN), or total serum bilirubin >1 × ULN;
- Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m²;
- Fasting blood glucose ≥7 mmol/L or <3.9 mmol/L; or HbA1c ≥6.5%;
- Fasting triglycerides ≥4.5 mmol/L;
- Hemoglobin <110 g/L for male participants, <100 g/L for female participants;
- International normalized ratio (INR) >1.3;
- Serum calcitonin ≥20 pg/mL (i.e. 20 ng/L);
- Clinically significant abnormalities in thyroid function tests at screening;
- Positive hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis antibody at screening, or findings judged clinically meaningful by the investigator;
- Any laboratory abnormality of clinical significance that, in the investigator's opinion, may interfere with evaluation of study results;
- Blood loss or blood donation exceeding 400 mL, or receipt of blood or blood-component transfusion within 3 months before drug administration; or planned blood donation during the study;
- Vaccination within 1 month prior to screening, or planned vaccination during the study;
- Alcohol and tobacco overuse: average alcohol intake ≥14 standard units per week within 6 months before screening (1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); average daily cigarette consumption ≥5 cigarettes, and inability to abstain during the study; positive blood alcohol test or result >0 mg/100 mL;
- Consumption of special diets (including grapefruit, pomelo, etc.) or strenuous exercise within 14 days before drug administration; or intake of chocolate, any caffeine- or xanthine-containing food or beverages within 48 hours before drug administration; or other factors at screening that may affect drug absorption, distribution, metabolism or excretion;
- History of drug abuse or illicit-drug use within 1 year prior to drug administration; or positive urine drug screen;
- Female participants who are pregnant or lactating;
- Intolerance to venipuncture; or history of vasovagal reaction to injection or blood;
- Inability to maintain consistent diet and physical activity during the study; or special dietary requirements preventing compliance with standardized study diet;
- Participation in another clinical trial within 3 months prior to drug administration (excluding screening-only participation without study drug administration or non-interventional studies);
- Other conditions that, in the investigator's opinion, may affect PK assessment, may prevent the participant from completing the study, may expose the participant to substantial risk from study participation, or otherwise render the participant unsuitable or unable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230061
Wei Hu, PhD, +86-13856086475, hwgcp@ayefy.com
About this study
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.
This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.
The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing.
The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.
- Being tested
- UBT251, Metformin hydrochloride, Warfarin Sodium, Atorvastatin calcium, Digoxin
- Keywords
- UBT251 Injection, Drug-Drug Interactions, Pharmacokinetics, Pharmacodynamics, Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT251Drug
Subcutaneous injection administered once weekly with dose escalation
Metformin hydrochlorideDrug
Oral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.
Warfarin SodiumDrug
Oral administration. Warfarin sodium will be given as 2 single doses.
Atorvastatin calciumDrug
Oral administration. Atorvastatin calcium will be given as 2 single doses.
DigoxinDrug
Oral administration. Digoxin will be given as 2 single doses.
| Study group | Role | What they receive |
|---|---|---|
| UBT251 | Experimental | This study contains two cohorts. Cohort 1: Participants will first receive multiple-dose metformin, then a single-dose warfarin after a 7-day washout period, with PK/PD sampling for both treatments. Following a 20-week weekly dose-escalation phase of UBT251, metformin will be administered 24 hours after the 5th consecutive fixed-dose UBT251 injection, and warfarin will be given 24 hours after the 6th injection. Dosing and PK/PD sampling procedures will match those of the single-drug phase.
Cohort 2: Participants will receive single-dose atorvastatin and digoxin separated by a 7-day washout period, with PK sampling for each drug. After the 20-week UBT251 weekly dose-escalation phase, atorvastatin will be given 24 hours after the 5th consecutive fixed-dose UBT251 injection, and digoxin will be administered 24 hours after the 6th injection. PK sampling procedures will be consistent with those of the single-drug treatment phase. Receives: Drug: UBT251; Drug: Metformin hydrochloride; Drug: Warfarin Sodium; Drug: Atorvastatin calcium; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)
Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.
Measured: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses
Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin
Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.
Measured: From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses
Secondary outcomes (70)
Peak Plasma Concentration (Cmax) of metformin in Cohort 1
Peak plasma concentration (Cmax) of metformin at steady-state in Cohort 1
Measured: Up to 30 hours following last dose at steady-state
Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1
Time to reach peak plasma concentration (Tmax) of metformin at steady-state in Cohort 1
Measured: Up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC0-t) of metformin at steady-state in Cohort 1
Measured: Pre-dose and up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) of metformin at steady-state in Cohort 1
Measured: Pre-dose and up to 30 hours following last dose at steady-state
Apparent volume of distribution (Vz/F) of metformin in Cohort 1
Apparent volume of distribution (Vz/F) of metformin at steady-state in Cohort 1
Measured: Pre-dose and up to 30 hours following last dose at steady-state
Apparent total clearance (CL/F) of metformin in Cohort 1
Apparent total clearance (CL/F) of metformin at steady-state in Cohort 1
Measured: Up to 30 hours following last dose at steady-state
Terminal elimination rate constant (λz) of metformin in Cohort 1
Terminal elimination rate constant (λz) of metformin at steady-state in Cohort 1
Measured: Pre-dose and up to 30 hours following last dose at steady-state
Terminal half-life (t1/2z) of metformin in Cohort 1
Terminal elimination half-life (t1/2z) of metformin at steady-state in Cohort 1
Measured: Pre-dose and up to 30 hours following last dose at steady-state
Peak Plasma Concentration (Cmax) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).
Measured: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Maximum Plasma Concentration (Cmax) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Measured: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Measured: Pre-dose and up to 72 hours following single dose
Apparent Clearance (CL/F) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent clearance (CL/F).
Measured: Pre-dose and up to 72 hours following single dose
Apparent Volume of Distribution (Vz/F) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).
Measured: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Measured: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).
Measured: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Measured: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Measured: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Measured: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).
Measured: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Measured: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Measured: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Measured: Pre-dose and up to 120 hours following single dose
Terminal Rate Constant (λz) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Measured: Pre-dose and up to 120 hours following single dose
Terminal Half-Life (t1/2z) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Measured: Pre-dose and up to 120 hours following single dose
Apparent Clearance (CL/F) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent clearance (CL/F).
Measured: Pre-dose and up to 120 hours following single dose
Apparent Volume of Distribution (Vz/F) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).
Measured: Pre-dose and up to 120 hours following single dose
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).
Measured: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the INR-Time Curve (AUCINR) of Warfarin Under UBT251 Steady-State in Cohort 2
Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin, when administered under UBT251 steady-state conditions. This endpoint evaluates area under the INR-time curve (AUCINR).
Measured: Baseline to 168 hours
Maximum Observed INR (INRmax) of Warfarin Under UBT251 Steady-State in Cohort 2
Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin administered under UBT251 steady-state conditions. This endpoint evaluates maximum observed INR (INRmax).
Measured: Baseline to 168 hours
Change in Body Weight From Pre-treatment Baseline Following UBT251 Dosing in Cohort 2
Body weight is measured at baseline and scheduled visits. This endpoint evaluates body weight change relative to pre-UBT251 baseline.
Measured: throughout UBT251 titration period
Incidence, Maximum Severity Grade, and Duration of Adverse Events and Serious Adverse Events During UBT251 Treatment
All adverse events and serious adverse events are actively monitored and recorded throughout the study. This outcome assesses the incidence defined as percentage of affected subjects, maximum severity grade classified according to CTCAE criteria, and duration in days of each adverse event.
Measured: Baseline up to Study Day 190
Changes From Baseline in Vital Signs During UBT251 Treatment
Vital signs including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature are measured using standard clinical equipment at scheduled visits. This outcome evaluates absolute and relative changes from baseline throughout the study period.
Measured: Baseline up to Study Day 190
Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters During UBT251 Treatment
12-lead ECGs are collected at scheduled visits and can be additionally performed at any time for safety monitoring. Participants rest in a supine position for at least 5 minutes before testing. Assessed parameters include RR interval, PR interval, heart rate, QRS interval, QT interval, QTc interval, and QTcF calculated by Fredericia's formula. This outcome evaluates parameter changes from baseline and clinically significant abnormal ECG findings.
Measured: Baseline up to Study Day 190
Clinically Significant Abnormal Findings on Complete Physical Examination During UBT251 Treatment
Complete physical examinations are performed at scheduled study visits, covering general condition, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, spine, and extremities. This outcome summarizes all clinically significant abnormal physical examination findings compared with baseline throughout the study period.
Measured: Baseline up to Study Day 190
Changes From Baseline in Safety Laboratory Parameters During UBT251 Treatment
Safety laboratory tests include hematology, urinalysis, serum biochemistry, electrolytes, blood glucose, blood lipids, cardiac enzymes, lipase, amylase, coagulation function, glycated hemoglobin, procalcitonin, thyroid function tests, and infectious disease screening. This outcome evaluates changes from baseline and clinically significant laboratory abnormalities.
Measured: Baseline up to Study Day 190
Incidence of Positive Anti-UBT251 Binding Antibodies in Subjects Receiving UBT251
Validated immunoassay is used as the measurement tool to detect anti-UBT251 binding antibodies. This outcome assesses incidence (percentage of subjects with positive binding antibodies) at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Measured: Baseline up to Study Day 190
Antibody Titer Level of Anti-UBT251 Binding Antibodies in Antibody-Positive Subjects
Validated immunoassay is used as the measurement tool to determine antibody titer. This outcome reports titer levels for specimens confirmed positive for anti-UBT251 binding antibodies at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Measured: Baseline up to Study Day 190
Incidence of Positive Anti-UBT251 Neutralizing Antibodies (If Applicable) in Subjects Receiving UBT251
Validated cell-based neutralizing antibody assay is used as the measurement tool. This outcome assesses incidence (percentage of subjects with positive neutralizing antibodies), if applicable, at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Measured: Baseline up to Study Day 190
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start27 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug Interaction (DDI)Studies of the same condition, open and under way.
- More trials run by The United Bio-Technology (Hengqin) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785934
- Sponsor's protocol ID
- TUL-UBT251(Ⅰ-6)202508
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.
- ClinicalTrials.gov ID
- NCT07785934
- Acronym / sponsor ID
- TUL-UBT251(Ⅰ-6)202508
- Keywords
- UBT251 Injection, Drug-Drug Interactions, Pharmacokinetics, Pharmacodynamics, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.
The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing.
The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UBT251 | Experimental | Drug: UBT251, Drug: Metformin hydrochloride, Drug: Warfarin Sodium, Drug: Atorvastatin calcium, Drug: DigoxinThis study contains two cohorts. Cohort 1: Participants will first receive multiple-dose metformin, then a single-dose warfarin after a 7-day washout period, with PK/PD sampling for both treatments. Following a 20-week weekly dose-escalation phase of UBT251, metformin will be administered 24 hours after the 5th consecutive fixed-dose UBT251 injection, and warfarin will be given 24 hours after the 6th injection. Dosing and PK/PD sampling procedures will match those of the single-drug phase. Cohort 2: Participants will receive single-dose atorvastatin and digoxin separated by a 7-day washout period, with PK sampling for each drug. After the 20-week UBT251 weekly dose-escalation phase, atorvastatin will be given 24 hours after the 5th consecutive fixed-dose UBT251 injection, and digoxin will be administered 24 hours after the 6th injection. PK sampling procedures will be consistent with those of the single-drug treatment phase. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with overweight or obesity, aged 18-45 years inclusive; Cohort 1 includes male participants only, and Cohort 2 includes both male and female participants.
- Body weight ≥50.0 kg, body mass index (BMI) ranging from 24.0 to 35.0 kg/m² inclusive (BMI = weight(kg)/height²(m²)).
- Participants (including their partners) have no plan to conceive from screening through 6 months after study completion, are willing to adopt contraceptive measures specified in the study, and have no plan to donate sperm or ova within 6 months after trial completion.
- Participants are able to communicate well with investigators, have fully understood this study, voluntarily participate in it, understand and comply with all study requirements, and provide written informed consent.
Key exclusion criteria (36 listed)
- Known hypersensitivity or intolerance to investigational product or its excipients, or hypersensitivity to other GLP-1, GIP, GCG receptor agonists; or prior history of multiple or severe clinically significant drug hypersensitivity reactions; or active allergic disease or high-sensitivity constitution;
- History or evidence of any of the following diseases:
- Severe infection, trauma or major surgical operation within 4 weeks prior to screening; or planned surgical procedure during the study;
- History of bariatric surgery for obesity;
- Use of dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1, GCG, GIP or amylin-targeted agents (e.g. exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, mazdutide, etc.) within 2 months before drug administration; or prior intolerance to the above-mentioned agents;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBT251Subcutaneous injection administered once weekly with dose escalation | Drug | UBT251 |
| Metformin hydrochlorideOral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations. | Drug | UBT251 |
| Warfarin SodiumOral administration. Warfarin sodium will be given as 2 single doses. | Drug | UBT251 |
| Atorvastatin calciumOral administration. Atorvastatin calcium will be given as 2 single doses. | Drug | UBT251 |
| DigoxinOral administration. Digoxin will be given as 2 single doses. | Drug | UBT251 |
Primary outcome
Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)
Time frame: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses
Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.
Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin
Time frame: From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses
Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.
70 secondary outcomes
Peak Plasma Concentration (Cmax) of metformin in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Apparent volume of distribution (Vz/F) of metformin in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Apparent total clearance (CL/F) of metformin in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Terminal elimination rate constant (λz) of metformin in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Terminal half-life (t1/2z) of metformin in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Peak Plasma Concentration (Cmax) of S-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of S-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of S-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of S-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of S-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of S-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of R-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of R-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of R-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of R-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of R-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of R-warfarin in Cohort 1
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 1
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Maximum Plasma Concentration (Cmax) of Atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of Atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of Atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Apparent Clearance (CL/F) of Atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Apparent Volume of Distribution (Vz/F) of Atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 2-hydroxy-atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 2-hydroxy-atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 2-hydroxy-atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 2-hydroxy-atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 2-hydroxy-atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 2-hydroxy-atorvastatin in Cohort 2
Time frame: Pre-dose and up to 72 hours following single dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UBT251, Metformin hydrochloride and Warfarin Sodium in people with Drug Drug Interaction (DDI) and Pharmacokinetics and Pharmacodynamics, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, PhD (+86-13856086475, hwgcp@ayefy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞) (time frame: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.