drugset
drugset / Trial / NCT06981299

A Phase 1 Study of PROT-001.

NCT06981299 ↗

Phase 1 Completed 102 enrolled Protego Biopharma Pty Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-05-29
Primary completion
2025-12-23
Completion
2025-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Digoxin Other / unclassified 0.25 mg —
Subject PROT-001 Small molecule 15 mg Oral
Subject PROT-001 Small molecule 75 mg Oral
Subject Rosuvastatin Small molecule 10 mg —

Indications

No indication recorded.