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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

Recruiting
18 - 65 years of age
Both
Phase 1

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Overview

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.

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:
    1. 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 details

T2DM

NCT05996380

Jiangsu HengRui Medicine Co., Ltd.

25 January 2024

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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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