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RECRUITING
NCT07469891
PHASE1

A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms

Sponsor: Prelude Therapeutics

View on ClinicalTrials.gov

Summary

This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]). The study consists of a dose-escalation phase followed by a dose-expansion phase to further evaluate selected dose level(s).

Official title: A Phase 1, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04

Completion Date

2028-04

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

PRT12396

PRT12396 is an investigational oral capsule administered twice daily at the assigned dose level or RDE. Capsules are swallowed whole with water and may be taken one hour before or two hours after meals.

Locations (1)

START Midwest, LLC

Grand Rapids, Michigan, United States