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

NCT05996380 | Unknown Phase 1

• 1 other identifier: SHR-3167-101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

SHR-3167

EXPERIMENTAL

Drug: SHR-3167

SHR-3167 Placebo

PLACEBO COMPARATOR

Drug: SHR-3167 Placebo

Interventions

SHR-3167 DRUG

SHR-3167, Single administration

SHR-3167

SHR-3167 Placebo DRUG

SHR-3167 Placebo Single administration

SHR-3167 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years ≤ age ≤ 55 years (healthy subjects) or 18 years ≤ age ≤ 65 years (T2DM patients)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Meng Sun

CONTACT

+86 18036618718; meng.sun@hengrui.com

Zeming lin

CONTACT

+86 17721288239; zeming.lin.zl5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 18, 2023
• Study Start: June 9, 2023
• Primary Completion: January 25, 2024
• Study Completion: April 28, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-08

Locations

CN (1)