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Clinical trial

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.

NCT06981299 is registered in ClinicalTrials.gov with Protego Biopharma Pty Ltd as lead sponsor.

NCT NCT06981299
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Protego Biopharma Pty Ltd
Phase
Phase 1
Overall status
Completed
Start date
May 29, 2025
Completion date
December 23, 2025
Enrollment
102 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy