NCT05635084

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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Beijing Inno Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	YN001	Dose ranges from 2-90mg
DRUG	Placebo for YN001	5% dextrose injection to mimic the YN001

Timeline

• Start date: 2022-12-16
• Primary completion: 2024-08-09
• Completion: 2024-08-09
• First posted: 2022-12-02
• Last updated: 2024-11-18

Locations

1 site across 1 country: Australia