Healthy SubjectsPhase 1NCT05347758
A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
A Phase 1 study testing HRS-7535 in people with Healthy Subjects, run by Shandong Suncadia Medicine Co., Ltd..
Trial summary
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HRS-7535
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 15 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
- Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from screening to at least 6 months after the final dose of study drug;
- Able and willing to provide written informed consent and to comply with the study protocol;
- Physical examination, vital signs are normal or are judged not clinically significant by the investigator;
Who cannot join
- Participants with any abnormal results and judged clinically significant by the investigator;
- HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;
- Abnormal ECG that is clinically significant, or QTcF >450 msec;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years;
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- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, history of pancreatitis or symptomatic gallbladder disease;
- History of gastric emptying anomalies (gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer) ;
- Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems;
- Use any prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration;
- Subject who received bariatric surgery or procedures, or use of weight-reducing drugs within 3 months prior to administration, or body weight change of more than ±10% within 3 months prior to administration;
- Use any drugs that may affect glucose metabolism were used within 1 month before administration.
- Suspected allergy to any ingredient in the study drug;
- Participation in clinical trials of any drug or medical device within 3 months before screening;
- History of regular alcohol consumption exceeding 14 drinks per week within 6 months before screening;
- More than 5 cigarettes per day or cigarettes within 3 months before screening;
- Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment;
- Strenuous exercise in 48 hours before treatment;
- Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
- Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug;
- Subjects can't tolerate venipuncture;
- Subjects have special dietary requirements and cannot comply with the unified diet;
- Other conditions judged by the investigator to be not suitable to participate in the trial;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- HRS-7535, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535Drug
Drug: HRS-7535
PlaceboDrug
Drug: Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Drug: HRS-7535 Receives: Drug: HRS-7535 |
| Group B | Placebo comparator | Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse Events
Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;
Measured: Day-2 to last follow-up
Secondary outcomes (26)
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t);
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞);
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Cmax
Maximum observed concentration (Cmax);
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Tmax
Time to maximum observed concentration (Tmax);
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - t1/2
Terminal elimination half-life (t1/2)
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - CL/F
Apparent clearance (CL/F);
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Vz/F
Apparent volume of distribution (Vz/F);
Measured: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss
Area under the plasma concentration-time curve from time zero to tau at steady state (AUC0-τ,ss)
Measured: pre-last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss
AUC0-t at steady state (AUC0-t,ss)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss
AUC0-∞ at steady state (AUC0-∞,ss)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss
Tmax at steady state (Tmax,ss)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss
Cmax at steady state (Cmax,ss)
Measured: pre- last doseto 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss
Ctrough at steady state (Ctrough,ss)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss
Cavg at steady state (Cavg,ss)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - DF
Degree of fluctuation at steady state (DF)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F
Vz/F at steady state (Vz,ss/F)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - CLss/F
CL/F at steady state (CLss/F)
Measured: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss
t1/2 at steady state (t1/2,ss)
Measured: pre- last dose to 96 hours post- last dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose
Measured: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin
Measured: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide
Measured: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon
Measured: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine
Measured: pre-dose up to 96 hours after the last dose
PD profile of multiple doses of HRS-7535 - HbA1c
Measured: pre-dose up to 96 hours after the last dose
PD profile of multiple doses of HRS-7535 - 5-points glucose profile
Measured: pre-dose up to 24 hours after the last dose
PD profile of multiple doses of HRS-7535 - weight
Measured: pre-dose up to 96 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion18 Sep 2022 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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
- Randomised
- Intervention model
- Sequential
- Model description
- HRS-7535 tablet compared with placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347758
- Sponsor's protocol ID
- HRS-7535-101
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05347758
- Acronym / sponsor ID
- HRS-7535-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 18 Sep 2022 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 26 Apr 2022 (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 randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- HRS-7535 tablet compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS-7535Drug: HRS-7535 |
| Group B | Placebo comparator | Drug: PlaceboDrug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
- Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from screening to at least 6 months after the final dose of study drug;
- Able and willing to provide written informed consent and to comply with the study protocol;
- Physical examination, vital signs are normal or are judged not clinically significant by the investigator;
Key exclusion criteria (23 listed)
- Participants with any abnormal results and judged clinically significant by the investigator;
- HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;
- Abnormal ECG that is clinically significant, or QTcF >450 msec;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
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 |
|---|---|---|
| HRS-7535Drug: HRS-7535 | Drug | Group A |
| PlaceboDrug: Placebo | Drug | Group B |
Primary outcome
Number of adverse Events
Time frame: Day-2 to last follow-up
Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;
26 secondary outcomes
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Cmax
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Tmax
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - t1/2
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - CL/F
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - Vz/F
Time frame: pre-dose to 96 hours post-dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss
Time frame: pre-last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss
Time frame: pre- last doseto 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - DF
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - CLss/F
Time frame: pre- last dose to 96 hours post- last dose
Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss
Time frame: pre- last dose to 96 hours post- last dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon
Time frame: pre-dose to 24 hours post-dose
Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine
Time frame: pre-dose up to 96 hours after the last dose
PD profile of multiple doses of HRS-7535 - HbA1c
Time frame: pre-dose up to 96 hours after the last dose
PD profile of multiple doses of HRS-7535 - 5-points glucose profile
Time frame: pre-dose up to 24 hours after the last dose
PD profile of multiple doses of HRS-7535 - weight
Time frame: pre-dose up to 96 hours after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-7535 in people with Healthy Subjects, run by Shandong Suncadia Medicine Co., Ltd..
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 5 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimei Xu (0518-82342973, yimei.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse Events (time frame: Day-2 to last follow-up). 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 26 Apr 2022.