Akeso
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.
Healthy Male Subjects
AK104 (before the change)
AK104 (after the change)
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 132 participants |
Masking: | Quadruple |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | October 26, 2022 |
Estimated Primary Completion Date : | January 9, 2023 |
Estimated Study Completion Date : | March 11, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: AK104 (after the change) Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. |
Drug: AK104 (after the change) |
Active Comparator: AK104 (before the change) Drug: AK104 (before the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. |
Drug: AK104 (before the change) |
Ages Eligible for Study: | 18 Years to 45 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.