NCT06111196

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects

A Randomized, Double-blind, Single-dose, Three-arm Parallel Group, Phase I Study to Compare the Pharmacokinetics and Safety of BAT3306 Versus KEYTRUDA® Administered in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects

Detailed description

A Randomized, Double-blind, Single-dose, Three-arm Parallel Group, Phase I Study to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection	100mg/4ml;single dose;intravenous injection
DRUG	Pembrolizumab injection	100mg/4ml;single dose;intravenous injection

Timeline

• Start date: 2023-11-05
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2023-11-01
• Last updated: 2024-10-30

Locations

1 site across 1 country: China