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

NCT06111196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-10-30

No results posted yet for this study

Summary

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

Conditions

  • Healthy Male Subjects

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Weiyong Li · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-05
Primary Completion
2024-06-11
Completion
2024-06-11

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06111196 on ClinicalTrials.gov