ClinicalTrials.gov ID NCT05781399
Sponsor Jnana Therapeutics
Information provided by Jnana Therapeutics (Responsible Party)
Last Update Posted 2024-07-30
Study Overview
The goal of Parts A and B of this Phase 1, first-in-human, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD) ascending doses of oral JNT-517 in healthy participants. In Part C, the goal is to evaluate the differences in bioavailability between a tablet and suspension formulation of JNT-517 and the food effect in healthy volunteers. All participants in Part C will receive JNT-517. The goal of Part D is to assess the safety, tolerability, PK, and effect on urinary Phe and other amino acids of JNT-517 in participants with phenylketonuria (PKU). Participants in Part D will receive either JNT-517 or placebo and will be blinded to their treatment assignment.
The study consists of 4 parts:
- Part A: SAD in healthy participants -randomized, double-blind, placebo-controlled
- Part B: MAD in healthy participants (14 days)-randomized, double-blind, placebo-controlled
- Part C: Relative bioavailability of 2 formulations and food effect in healthy participants-randomized, open-label
- Part D: Phase 1b in participants with PKU (4 weeks)-randomized, double-blind, placebo-controlled
In each part, participants will complete a Screening Period, a Treatment Period, and a Follow-up Period for safety.