A Phase 1 interventional study of AK104 (before the change) and AK104 (after the change) in Healthy Male Subjects, sponsored by Akeso. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Akeso · Phase 1, Interventional, and Other
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.
Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes.
Drug: AK104 (after 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)
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
Pilot study: Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to day 30
Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)
Time frame: From pre-dose to day 29
Area under the plasma concentration-time curve (AUC0-t)
Time frame: From pre-dose to day 29
Maximum plasma concentration (Cmax)
Time frame: From pre-dose to day 29
Volume of distribution (Vd)
Time frame: From pre-dose to day 29
Clearance (CL)
Time frame: From pre-dose to day 29
Ratio of AUC0-t/AUC0-infinity
Time frame: From pre-dose to day 29
Time to maximum concentration (Tmax)
Time frame: From pre-dose to day 29
Half-life (t1/2)
Time frame: From pre-dose to day 29
Anti-drug Antibody (ADA)
Number and percentage of subjects with detectable ADA
Time frame: From pre-dose to day 29
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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