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

T2DM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996380
• Other study ID #: SHR-3167-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 9, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: August 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Meng Sun
• Phone: +86 18036618718
• Email: meng.sun[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: April 28, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• T2DM

Intervention

Drug:
• SHR-3167
SHR-3167, Single administration
• SHR-3167 Placebo
SHR-3167 Placebo Single administration

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)