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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 I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
106
estimated
Study population
Healthy volunteers
Key I/E criteria
•BMI 19-28•Healthy volunteers
Primary endpoint
•Number of adverse Events
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;
2. 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);
3. 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;
4. Able and willing to provide written informed consent and to comply with the study protocol;
5. Physical examination, vital signs are normal or are judged not clinically significant by the investigator;
Exclusion criteria
1. Participants with any abnormal results and judged clinically significant by the investigator;
2. HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;
4. Abnormal ECG that is clinically significant, or QTcF >450 msec;
5. 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;
6. Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years;
7. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, history of pancreatitis or symptomatic gallbladder disease;
8. History of gastric emptying anomalies (gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer) ;
9. Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems;
10. Use any prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration;
11. 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;
12. Use any drugs that may affect glucose metabolism were used within 1 month before administration.
13. Suspected allergy to any ingredient in the study drug;
14. Participation in clinical trials of any drug or medical device within 3 months before screening;
15. History of regular alcohol consumption exceeding 14 drinks per week within 6 months before screening;
16. More than 5 cigarettes per day or cigarettes within 3 months before screening;
17. 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;
18. Strenuous exercise in 48 hours before treatment;
19. 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;
20. 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;
21. Subjects can't tolerate venipuncture;
22. Subjects have special dietary requirements and cannot comply with the unified diet;
23. Other conditions judged by the investigator to be not suitable to participate in the trial;
Endpoints (27)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointPD profile of multiple doses of HRS-7535 - weight
Time frame:pre-dose up to 96 hours after the last dose
descriptive
Glycemic / diabetes
5 endpointsPharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose
Time frame:pre-dose to 24 hours post-dose
descriptive
Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin
Time frame:pre-dose to 24 hours post-dose
descriptive
Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide
Time frame:pre-dose to 24 hours post-dose
descriptive
PD profile of multiple doses of HRS-7535 - HbA1c
Time frame:pre-dose up to 96 hours after the last dose
descriptive
PD profile of multiple doses of HRS-7535 - 5-points glucose profile
Time frame:pre-dose up to 24 hours after the last dose
descriptive
Safety / tolerability / PK
19 endpointsNumber of adverse Events
Time frame:Day-2 to last follow-up
event count, event
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t
Time frame:pre-dose to 96 hours post-dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞
Time frame:pre-dose to 96 hours post-dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Cmax
Time frame:pre-dose to 96 hours post-dose
concentration, descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Tmax
Time frame:pre-dose to 96 hours post-dose
concentration, descriptive
Pharmacokinetic (PK) profile of HRS-7535 - t1/2
Time frame:pre-dose to 96 hours post-dose
concentration, descriptive
Pharmacokinetic (PK) profile of HRS-7535 - CL/F
Time frame:pre-dose to 96 hours post-dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Vz/F
Time frame:pre-dose to 96 hours post-dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss
Time frame:pre-last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss
Time frame:pre- last dose to 96 hours post- last dose
concentration, descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss
Time frame:pre- last doseto 96 hours post- last dose
concentration, descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - DF
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - CLss/F
Time frame:pre- last dose to 96 hours post- last dose
descriptive
Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss
Time frame:pre- last dose to 96 hours post- last dose
concentration, descriptive
Other (unclassified)
2 endpointsPharmacodynamic (PD) profile of doses of HRS-7535 - glucagon
Time frame:pre-dose to 24 hours post-dose
descriptive
Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine
Time frame:pre-dose up to 96 hours after the last dose
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.