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A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects

NCT05559554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.

Conditions

  • Healthy Male Subjects

Interventions

DRUG

AK104 (before the change)

Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.

DRUG

AK104 (after the change)

Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.

Sponsors & Collaborators

Principal Investigators

  • Xin Li, MD · The Third Hospital of Changsha

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2023-03-24
Completion
2023-04-06

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 NCT05559554 on ClinicalTrials.gov