A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country52 target enrollmentJune 9, 2023

ConditionsT2DM

InterventionsSHR-3167 SHR-3167 Placebo

DrugsSHR-3167 SHR-3167 Placebo

Overview

Phase: Phase 1
Intervention: SHR-3167
Conditions: T2DM
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 52
Locations: 1
Primary Endpoint: Safety endpoints: Number of Adverse Events
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, single-dose escalation trial was designed. There are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg, 100 mg and 150 mg (optional). Eight healthy adult subjects or T2DM patients in each dose group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned to subcutaneously injection of SHR-3167 or placebo according to 3:1 ratio.

Registry

clinicaltrials.gov

Start Date

June 9, 2023

End Date

April 28, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, 18 years ≤ age ≤ 55 years (healthy subjects) or 18 years ≤ age ≤ 65 years (T2DM patients)
•18.5 kg/m2≤ Body mass index (BMI) \<26.0 kg/m2 (healthy subjects) or 18.5 kg/m2≤ BMI \<35.0kg/m2 (T2DM patients), and male weight ≥50kg and female weight ≥45kg
•T2DM patients: 7.0% ≤ HbA1c ≤9.5%, 7.5mmol/L≤ fasting blood glucose ≤15mmol/L
•Healthy subjects: 3.9 mmol/L\< fasting blood glucose \< 6.1mmol/L and HbA1c ≤6.0% at screening
•Signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria

•History of significant multiple and/or severe drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product
•Presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, hematological, neurological, or psychiatric diseases or disorders.
•History of severe cardiovascular and cerebrovascular disease, including heart failure (NYHA class II to IV), myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, 6 months before screening to before randomization;
•T2DM patients:
•a) Severe hypoglycemia, frequent hypoglycemia, ketoacidosis, or hypertonic coma from 6 months before screening to before randomization; b) Known proliferative diabetic retinopathy ordiabetic macular edema, or non-proliferative diabetic retinopathy requiring treatment during the trial;
•Those who had a severe infection, severe trauma, or had undergone surgery in the 12 weeks prior to screening, or planned to undergo surgery during the trial
•Participants who participated in a clinical trial of any other drug or medical device from 3 months prior to screening to before randomization or planned to participate during the study period