NCT05337267

Phase I Study of Sintilimab in Healthy Chinese Male Subjects

Phase I Study to Evaluate PK Similarity of Recombinant Fully Human Anti-programmed Death Receptor 1 Monoclonal Antibody Injection Before and After IBI308 Manufacturing Process Change in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process，also to determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy male subjects.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	sintilimab (after the change)	0.3mg/kg，I.V.，single dose
DRUG	sintilimab (before the change)	0.3mg/kg，I.V.，single dose

Timeline

• Start date: 2022-04-13
• Primary completion: 2023-05-24
• Completion: 2023-07-24
• First posted: 2022-04-20
• Last updated: 2023-08-21

Locations

1 site across 1 country: China