Clinical Trial

A Phase 1 Study of PROT-001.

Completed Phase 1
View on ClinicalTrials.gov →
Summary
A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Multi-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PROT-001, the Effect of Food and Age on the Pharmacokinetics of PROT-001, and the Effect of PROT-001 on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Adult Participants.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-05-13; most recent amendment 2026-01-29.
Status change: Recruiting → Completed 2026-01-20
Status change: Not Yet Recruiting → Recruiting 2025-05-28
Trial Details
NCT Number NCT06981299
Lead Sponsor Protego Biopharma Pty Ltd
Conditions Healthy
Enrollment 102 participants
Start Date 2025-05-29
Primary Completion 2025-12-23 (estimated)
Study Completion 2025-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-01-30