NCT05480579

A Study of IBI311 in Healthy Volunteers

A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	placebo	Dose4 placebo of single IV injection
BIOLOGICAL	IBI311	Dose2 IBI311 of single IV injection
BIOLOGICAL	IBI311	Dose4 IBI311 of single IV injection
BIOLOGICAL	placebo	Dose3 placebo of single IV injection
BIOLOGICAL	placebo	Dose1 placebo of single IV injection
BIOLOGICAL	IBI311	Dose1 IBI311 of single IV injection
BIOLOGICAL	IBI311	Dose 3 IBI311 of single IV injection
BIOLOGICAL	placebo	Dose2 placebo of single IV injection

Timeline

• Start date: 2022-08-10
• Primary completion: 2022-11-23
• Completion: 2023-01-19
• First posted: 2022-07-29
• Last updated: 2023-10-11

Locations

1 site across 1 country: China