Trials / Completed
CompletedNCT05559554
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
A Phase I Study to Evaluate the Similarity of Pharmacokinetic (PK) in AK104 (a PD-1/CTLA-4 Bispecific Antibody) With Different Manufacturing Process in Healthy Chinese Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Akeso · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-25
- Primary completion
- 2023-03-24
- Completion
- 2023-04-06
- First posted
- 2022-09-29
- Last updated
- 2024-05-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05559554. Inclusion in this directory is not an endorsement.