Assessing the safety and effects of SHR-3167 in healthy individuals 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 study is testing a new injection called SHR-3167 to see if it is safe and effective for healthy people and those with Type 2 Diabetes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05996380 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-3167 through a single injection. The trial includes six dose groups ranging from 0.5 mg to 150 mg, with participants randomly assigned to receive either SHR-3167 or a placebo in a 3:1 ratio. The study aims to enroll healthy subjects aged 18-55 and patients with Type 2 Diabetes aged 18-65, assessing various health metrics to determine the drug's effects.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-55 or Type 2 Diabetes patients aged 18-65 with specific health metrics.

Not a fit: Patients with significant health issues or severe drug allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for managing Type 2 Diabetes.

How similar studies have performed: Other studies have shown promise with similar pharmacological approaches, but this specific trial is novel.

Eligibility criteria

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

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Meng Sun

Conditions T2DM