A First-in-human Study of YN001 in Healthy Volunteers

Cardiovascular Diseases Clinical Trial

Official title: A First-in-human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered YN001 in Healthy Subjects

Status Recruiting

Clinical Trial Summary

This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.

Clinical Trial Description

A total of approximately 73 to 89 healthy male and female subjects will be enrolled into this study, it includes two parts: Part A is single ascending dose stage, approximately 49 to 65 healthy subjects will be enrolled into about eight to ten cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The doses will be progressively escalated, with a sentinel dosing strategy employed for all cohorts. Part B is multiple ascending dose stage, approximately 24 healthy subjects will be enrolled into about three cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The cohort M1 will be initiated by decision of SRC(safety review committee), then the doses will be progressively escalated. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases

• NCT number: NCT05635084
• Study type: Interventional
• Source: Beijing Inno Medicine Co., Ltd.
• Contact: Jamie Zhang, Master
• Phone: 01082599080
• Email: zhangjingmei@innovmed.co
• Status: Recruiting
• Phase: Phase 1
• Start date: December 16, 2022
• Completion date: August 29, 2024