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

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

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.

Study Overview

• Status: Recruiting
• Conditions: T2DM
• Intervention / Treatment: Drug: SHR-3167; Drug: SHR-3167 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Meng Sun; Phone Number: +86 18036618718; Email: meng.sun@hengrui.com
• Study Contact Backup: Name: Zeming lin; Phone Number: +86 17721288239; Email: zeming.lin.zl5@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
      • Principal Investigator: Yun Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, 18 years ≤ age ≤ 55 years (healthy subjects) or 18 years ≤ age ≤ 65 years (T2DM patients)
2. 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
3. T2DM patients: 7.0% ≤ HbA1c ≤9.5%, 7.5mmol/L≤ fasting blood glucose ≤15mmol/L
4. Healthy subjects: 3.9 mmol/L< fasting blood glucose < 6.1mmol/L and HbA1c ≤6.0% at screening
5. Signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. 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
2. Presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, hematological, neurological, or psychiatric diseases or disorders.
3. 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;

4. 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;

5. 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
6. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-3167	Drug: SHR-3167; SHR-3167, Single administration
Placebo Comparator: SHR-3167 Placebo	Drug: SHR-3167 Placebo; SHR-3167 Placebo Single administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints: Number of Adverse Events	A summary of adverse events, including Serious Adverse Events(SAEs)	Start of Treatment to end of study (approximately 92 days)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): January 25, 2024
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHR-3167-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No