NCT06416787

Safety and Tolerability of IBI355 in Healthy Volunteers

A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy volunteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	placebo	IBI355 7.5mg/kg Q4W
DRUG	IBI355	IBI355 1mg/kg Q4W

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-02-26
• Completion: 2025-04-02
• First posted: 2024-05-16
• Last updated: 2025-05-21

Locations

1 site across 1 country: China