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

NCT05347758 | Unknown Phase 1

• 1 other identifier: HRS-7535-101
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of adverse Events

  Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;

  Day-2 to last follow-up

Secondary Outcomes (26)

• Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t

  pre-dose to 96 hours post-dose

• Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞

  pre-dose to 96 hours post-dose

• Pharmacokinetic (PK) profile of HRS-7535 - Cmax

  pre-dose to 96 hours post-dose

• Pharmacokinetic (PK) profile of HRS-7535 - Tmax

  pre-dose to 96 hours post-dose

• Pharmacokinetic (PK) profile of HRS-7535 - t1/2

  pre-dose to 96 hours post-dose

Study Arms (2)

Group A

EXPERIMENTAL

Drug: HRS-7535

Drug: HRS-7535

Group B

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

HRS-7535 DRUG

Drug: HRS-7535

Group A

Placebo DRUG

Drug: Placebo

Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Central Study Contacts

Yimei Xu

CONTACT

0518-82342973; yimei.xu@hengrui.com

Shujin Cheng

CONTACT

0518-82342973; shujin.cheng@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-7535 tablet compared with placebo

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: September 18, 2022
• Study Completion: March 15, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04