NCT06110338

Safety and Tolerance Study of IBI355 in Health Volunteers

A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	placebo	placebo iv. once.
DRUG	IBI355	IBI355 iv. once.

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-09-20
• Completion: 2024-09-23
• First posted: 2023-10-31
• Last updated: 2024-10-21

Locations

1 site across 1 country: China