A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses

Official title

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses

Overview

This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.

Interventions

• Drug SHR-2906 Injection
  SHR-2906 injection, in different doses.
• Drug SHR-2906 Injection Placebo
  SHR-2906 injection placebo.

Primary outcome measures

• Incidence of adverse events (AEs). [Time frame: Part1: 57 days; Part2: 113 days.]
• Incidence of serious adverse events (SAEs). [Time frame: Part1: 57 days; Part2: 113 days.]

Secondary outcome measures (8)

• Maximum concentration (Cmax). [Time frame: Part1: 57 days; Part2: 113 days.]
• Time of maximum concentration (Tmax). [Time frame: Part1: 57 days; Part2: 113 days.]
• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last). [Time frame: Part1: 57 days; Part2: 113 days.]
• Area under the concentration-time curve from time zero to infinity (AUC0-inf). [Time frame: Part1: 57 days; Part2: 113 days.]
• Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau). [Time frame: Part1: 57 days; Part2: 113 days.]
• Elimination half-life (t1/2). [Time frame: Part1: 57 days; Part2: 113 days.]
• Apparent clearance (CL/F). [Time frame: Part1: 57 days; Part2: 113 days.]
• Apparent volume of distribution (Vz/F). [Time frame: Part1: 57 days; Part2: 113 days.]

Eligibility criteria

Inclusion criteria

• Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
• Males or females aged 18-55 years (inclusive);
• Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG);
• At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.

Exclusion criteria

• During screening, electrocardiogram (ECG) indicated that QTcF>450 ms in males and QTcF> 470 ms in females, as well as other abnormal ECG and vital signs that were judged by the researchers to have clinical significance;
• There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes, hypothyroidism or hyperthyroidism, etc.);
• There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or symptomatic gallbladder disease;
• Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases);
• Use of prescription drugs (excluding topical eye/nasal drops and creams without systemic exposure risk), over-the-counter drugs, food supplements, vitamins and Chinese herbal medicines (excluding conventional vitamins) within two weeks prior to screening;
• Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal peristalsis for a long time. For example: having undergone bariatric surgery or procedures (such as gastric banding), or having used weight-reducing drugs (including but not limited to orlistat) within 3 months before administration, or having a weight change of more than 10% within 3 months before administration;
• Those who have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Or the urine drug screening is positive;
• Blood donation of ≥200 mL within one month prior to screening; Or those who have donated ≥400 mL of blood or lost ≥400 mL of blood within 3 months prior to screening due to trauma or major surgical operations;
• Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;
• There are special dietary requirements and they cannot follow the uniform diet;
• Subjects who the researchers consider to have other factors that make them unsuitable for participating in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Hangzhou First People's Hospital — Hangzhou

Identifiers

NCT: NCT07280936 · SHR-2906-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗