Phase 1 Study of ATRS-2002 in Healthy Male Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Only males
Description
The study will be conducted in 4 dosing groups of 8 subjects each. Thirty-two healthy adult men will be randomly assigned to a treatment cohort and will receive either a single Subcutaneous (SC) dose of ATRS-2002 (abiraterone acetate), or a single oral dose of the commercially available formulation ...
The study will be conducted in 4 dosing groups of 8 subjects each. Thirty-two healthy adult men will be randomly assigned to a treatment cohort and will receive either a single Subcutaneous (SC) dose of ATRS-2002 (abiraterone acetate), or a single oral dose of the commercially available formulation of abiraterone acetate (Zytiga®). Additionally, for Cohorts 1 through 3, a single subject will be randomized as a sentinel subject to be dosed at least 24 hours prior to the rest of cohort (ROC). Dosing in the abiraterone acetate SC cohorts will be sequential and will start with subjects in the lowest SC dosing cohort (i.e., 25 mg). Dosing will not begin in the next highest SC dose cohort until all safety data, as well as available PK (Pharmacokinetic) data and TT levels, from the previous cohort(s) have been reviewed by the safety review committee (SRC e.g., Sponsor and Investigator) and it has been deemed safe to proceed to the next highest dose. Dosing in the oral abiraterone acetate cohort (Cohort 4) may begin at any time during the study.
Tracking Information
- NCT #
- NCT04879589
- Collaborators
- Antares Pharma Inc.
- Investigators
- Not Provided