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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

October 31, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

December 15, 2025

Conditions
Phenylketonuria
Interventions
DRUG

JNT-517 Suspension

JNT-517 in on-site compounded suspension

DRUG

Placebo Suspension

On-site compounded placebo suspension

DRUG

JNT-517 Tablet

JNT-517 tablets, 25 mg and 75 mg

DRUG

Placebo Tablet

Matching film-coated placebo tablet

Trial Locations (15)

2145

Westmead Hospital, Westmead

3004

Nucleus Network Melbourne, Melbourne

4101

Mater Misericordia Ltd, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

30329

Rare Disease Research, Atlanta

32610

University of Florida College of Medicine, Gainesville

33620

University of South Florida, Tampa

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

68198

University of Nebraska Medical Center, Omaha

75390

UT Southwestern Medical Center, Dallas

77030

University of Texas Health Science Center at Houston, Houston

84112

Utah Health - The University of Utah Hospital, Salt Lake City

97239

Oregon Health & Sciences University, Portland

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY