Phase 1 Study of ATRS-2002 in Healthy Male Adults

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title: Phase 1, Open-Label, Single-Ascending Dose, Parallel Group Study to Determine the Pharmacokinetics, Safety, and Tolerability of ATRS-2002 Administered Subcutaneously in Healthy Adult Males

Status Withdrawn

Clinical Trial Summary

To access the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ATRA-2002 against commercially available oral formulation of abiraterone acetate in healthy male adults

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04879589
• Study type: Interventional
• Source: Syneos Health
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 1, 2022
• Completion date: April 20, 2023