RecruitingPhase 1NCT07200596

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose Subcutaneous Injection of SHR-3045 in Healthy Subjects-A Randomized, Double-Blind, Dose-Escalating, Placebo-Controlled Phase I Study


Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

16 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called SHR-3045 in healthy volunteers to evaluate its safety, how well the body tolerates it, and how the body absorbs and eliminates it. This type of study is the first step before testing a drug in patients with a specific condition. **You may be eligible if...** - You are a healthy adult aged 18–55 - You have a body weight of at least 50 kg (men) or 45 kg (women) and a BMI between 19 and 28 - You have no significant medical history, abnormal physical findings, or lab abnormalities - You are willing to provide written consent and follow all study procedures **You may NOT be eligible if...** - You have participated in another drug or medical device trial in the past 3 months - You have a known medical condition or take regular medications - You have abnormal baseline lab tests or vital signs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-3045 Injection

SHR-3045 injection.

DRUGSHR-3045 Placebo Injection

SHR-3045 placebo injection.


Locations(1)

The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

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NCT07200596


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