Overweight , ObesityPhase 1NCT07922798
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
A Phase 1 study testing UBT48128 in people with Overweight , Obesity, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, randomized, double-blind, placebo-controlled, first-in-human, dose-escalation trial (with an open-label design for the first dose cohort), designed to evaluate the safety, tolerability, and PK/PD characteristics of UBT48128 tablets following single oral administration in healthy adult… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- UBT48128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2026to 30 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be able to communicate well with the investigator, have fully understood this study, participate voluntarily, understand and comply with all requirements of this study, and sign a written informed consent form before the trial.
- Aged 18-55 years (inclusive) at the time of signing the informed consent, healthy Chinese males or females.
- At screening, male body weight > 60 kg and female body weight > 50 kg, with a body mass index (BMI) within 19.0-30.0 kg/m² (inclusive).
- Body weight change within 3 months prior to screening ≤ 5% (based on self-report).
- At screening, glycated hemoglobin (HbA1c) < 6.5% and fasting blood glucose < 6.1 mmol/L.
- Female participants of childbearing potential or male participants must have no plan to reproduce or donate sperm/ova from the time of signing the informed consent form until 3 months after dosing, and must voluntarily adopt the contraceptive measures specified in the study.
Who cannot join
- A prior history of, or suspected hypersensitivity or allergic reactions to the investigational product ingredients or other GLP-1 receptor agonist drugs, or being of an allergic constitution (allergic to multiple drugs and foods);
- Suffering from clinically significant diseases/abnormalities within 1 year prior to screening or currently having clinically significant diseases/abnormalities (including but not limited to diseases of the neuropsychiatric, cardiovascular, respiratory, blood and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems);
- A personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or hereditary diseases that predispose to medullary thyroid carcinoma;
- A history of pancreatitis or concurrent symptomatic pancreatic disease at screening;
- A history of cholecystitis, or a past history of gallbladder disease that has been symptomatic (except for participants who have previously undergone cholecystectomy and are judged by the investigator as eligible for enrollment);
- Symptomatic hypoglycemia requiring medical intervention within 12 months prior to screening, or recurrent symptomatic hypoglycemia (≥ 2 episodes) within the past 6 months, or hypoglycemia unawareness;
- Optic neuropathy at screening, or high-risk factors for non-arteritic anterior ischemic optic neuropathy (NAION) within 6 months prior to screening;
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
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Guoping Yang, 13974817168
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of a Single Oral Dose of UBT48128 Tablets in Healthy Participants
This study is a single-center, randomized, double-blind, placebo-controlled, first-in-human, dose-escalation trial (with an open-label design for the first dose cohort), designed to evaluate the safety, tolerability, and PK/PD characteristics of UBT48128 tablets following single oral administration in healthy adult participants, the effect of food on the PK characteristics of UBT48128, the biotransformation and mass balance properties of UBT48128 in vivo, and its effect on the QT/QTc interval.
- Conditions
- Overweight , Obesity
- Being tested
- UBT48128, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT48128Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| UBT48128 | Experimental | Ascending single doses - 6 dose levels Receives: Drug: UBT48128 |
| Placebo | Placebo comparator | Ascending single doses - 6 dose levels Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..
Measured: Baseline to Day 6 and Day 13
Secondary outcomes (9)
Cmax
Measured: Baseline to Day 6 and Day 13
Tmax
Measured: Baseline to Day 6 and Day 13
AUC0-t
Measured: Baseline to Day 6 and Day 13
AUC0-∞
Measured: Baseline to Day 6 and Day 13
λz
Measured: Baseline to Day 6 and Day 13
t1/2
Measured: Baseline to Day 6 and Day 13
CL/F
Measured: Baseline to Day 6 and Day 13
Vz/F
Measured: Baseline to Day 6 and Day 13
MRT
Measured: Baseline to Day 6 and Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start29 Nov 2026 (estimated)
- Primary completion29 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT07922798
- Sponsor's protocol ID
- TUL-UBT48128（I-3）202610
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of a Single Oral Dose of UBT48128 Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07922798
- Acronym / sponsor ID
- TUL-UBT48128（I-3）202610
- Conditions
- Overweight , Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2026 (estimated)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Nov 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 study is a single-center, randomized, double-blind, placebo-controlled, first-in-human, dose-escalation trial (with an open-label design for the first dose cohort), designed to evaluate the safety, tolerability, and PK/PD characteristics of UBT48128 tablets following single oral administration in healthy adult participants, the effect of food on the PK characteristics of UBT48128, the biotransformation and mass balance properties of UBT48128 in vivo, and its effect on the QT/QTc interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBT48128 | Experimental | Drug: UBT48128Ascending single doses - 6 dose levels |
| Placebo | Placebo comparator | Drug: PlaceboAscending single doses - 6 dose levels |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be able to communicate well with the investigator, have fully understood this study, participate voluntarily, understand and comply with all requirements of this study, and sign a written informed consent form before the trial.
- Aged 18-55 years (inclusive) at the time of signing the informed consent, healthy Chinese males or females.
- At screening, male body weight > 60 kg and female body weight > 50 kg, with a body mass index (BMI) within 19.0-30.0 kg/m² (inclusive).
- Body weight change within 3 months prior to screening ≤ 5% (based on self-report).
- At screening, glycated hemoglobin (HbA1c) < 6.5% and fasting blood glucose < 6.1 mmol/L.
Key exclusion criteria (7 listed)
- A prior history of, or suspected hypersensitivity or allergic reactions to the investigational product ingredients or other GLP-1 receptor agonist drugs, or being of an allergic constitution (allergic to multiple drugs and foods);
- Suffering from clinically significant diseases/abnormalities within 1 year prior to screening or currently having clinically significant diseases/abnormalities (including but not limited to diseases of the neuropsychiatric, cardiovascular, respiratory, blood and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems);
- A personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or hereditary diseases that predispose to medullary thyroid carcinoma;
- A history of pancreatitis or concurrent symptomatic pancreatic disease at screening;
- A history of cholecystitis, or a past history of gallbladder disease that has been symptomatic (except for participants who have previously undergone cholecystectomy and are judged by the investigator as eligible for enrollment);
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 |
|---|---|---|
| UBT48128Administered orally | Drug | UBT48128 |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..
Time frame: Baseline to Day 6 and Day 13
9 secondary outcomes
Cmax
Time frame: Baseline to Day 6 and Day 13
Tmax
Time frame: Baseline to Day 6 and Day 13
AUC0-t
Time frame: Baseline to Day 6 and Day 13
AUC0-∞
Time frame: Baseline to Day 6 and Day 13
λz
Time frame: Baseline to Day 6 and Day 13
t1/2
Time frame: Baseline to Day 6 and Day 13
CL/F
Time frame: Baseline to Day 6 and Day 13
Vz/F
Time frame: Baseline to Day 6 and Day 13
MRT
Time frame: Baseline to Day 6 and Day 13
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 6 Nov 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 UBT48128 in people with Overweight , Obesity, 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Nov 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. Some participants in this study may receive a placebo. 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 Jie Wu (13764097870, wujie@tul.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,.. (time frame: Baseline to Day 6 and Day 13). 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 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.