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

NCT ID: NCT05347758

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-03-15

Brief 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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group A

Drug: HRS-7535

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

Drug: HRS-7535

Group B

Drug: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Drug: Placebo

Interventions

HRS-7535

Drug: HRS-7535

Intervention Type: DRUG

Placebo

Drug: Placebo

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yimei Xu

Role: CONTACT

yimei.xu@hengrui.com

0518-82342973

Shujin Cheng

Role: CONTACT

shujin.cheng@hengrui.com

0518-82342973

Other Identifiers

HRS-7535-101

Identifier Type: -

Identifier Source: org_study_id