NCT07190885

A Pharmacokinetic Study of YN001 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Beijing Inno Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, open-label study designed to evaluate the pharmacokinetics (PK), safety, and immunogenicity following a single dose administration in healthy adult volunteers.

Detailed description

This will be a single center, open-label, single dose study in Healthy volunteers. A total of approximately 24 healthy male and female participants will be enrolled into two dose groups (12 participants per dose group). The study will consist of a maximum 27-day screening period, a baseline period (Day -1), a treatment period (Day 1), a follow up period (Day 2-15). After completion of relevant assessments on Day 8, participants will be followed for an additional 7 days and will have a completion visit conducted via phone call on Day 15. The study is designed to refine PK profile of YN001 in Australian healthy volunteers to support further clinical development of YN001.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	YN001	YN001 administered via intravenous infusion. Participants will receive either 20 mg (Cohort 1) or 40 mg (Cohort 2).

Timeline

• Start date: 2025-11-18
• Primary completion: 2026-02-04
• Completion: 2026-02-18
• First posted: 2025-09-24
• Last updated: 2025-12-18

Locations

1 site across 1 country: Australia