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Completed Phase 1Phase 2 Interventional Accepts healthy volunteers

First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria

ClinicalTrials.gov ID: NCT05781399

Public ClinicalTrials.gov record NCT05781399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 1:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2, First-In-Human, Multiple Part, Single Ascending and Multiple Dose Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria

Study identification

NCT ID
NCT05781399
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
111 participants

Conditions and interventions

Interventions

  • JNT-517 Suspension Drug
  • JNT-517 Tablet Drug
  • Placebo Suspension Drug
  • Placebo Tablet Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 30, 2022
Primary completion
Jul 13, 2025
Completion
Jul 13, 2025
Last update posted
May 5, 2026

2022 – 2025

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
11
Facility City State ZIP Site status
University of Florida College of Medicine Gainesville Florida 32610
University of South Florida Tampa Florida 33620
Rare Disease Research Atlanta Georgia 30329
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
University of Nebraska Medical Center Omaha Nebraska 68198
Oregon Health & Sciences University Portland Oregon 97239
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
UT Southwestern Medical Center Dallas Texas 75390
University of Texas Health Science Center at Houston Houston Texas 77030
Utah Health - The University of Utah Hospital Salt Lake City Utah 84112

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05781399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05781399 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →