RecruitingPhase 1NCT07051603

SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

A Phase 1, Randomized, Double-Blind Placebo-Controlled Single and Multiple Dose Study Plus Food Effect Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SAL0140 in Healthy Chinese Subjects


Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Enrollment

82 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I safety study of a new investigational drug called SAL0140, given to healthy Chinese adult volunteers. The goal is to understand how the drug behaves in the body, how safe it is, and how it affects certain biological measures. **You may be eligible if:** - You are a healthy adult between 18 and 65 years old - Your weight and BMI fall within the study's specified normal range - All your physical exam, lab tests, ECG, and chest X-ray results are normal or only minimally abnormal - You agree to use effective contraception during the study **You may NOT be eligible if:** - You have a history of orthostatic hypotension or rapid heart rate when standing - You have used corticosteroids in the past 3 months - You have a personal or family history of abnormal heart rhythms or sudden death - You have abnormal ECG (QTcF > 450ms) or abnormal blood electrolytes - You smoke, drink heavily, or use illegal drugs - You have taken any prescription or over-the-counter medications or supplements in the past 14 days - You are pregnant, breastfeeding, or planning pregnancy during or within 1 month of the study - You have tested positive for hepatitis B, hepatitis C, syphilis, or HIV 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

DRUGSAL0140

In this part, SAL0140 tablets will be administered as a single or multiple oral dose.

DRUGSAL0140 placebo

In this part, SAL0140 placebo tablets will be administered as a single or multiple oral dose.


Locations(1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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NCT07051603


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