PhenylketonuriaPhase 1/2NCT05781399
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria
A Phase 1/2 study testing JNT-517 Suspension and JNT-517 Tablet in people with Phenylketonuria, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 15 sites in 2 countries.
Trial summary
The goal of Parts A and B of this Phase 1/2, 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Phenylketonuria
- What is being tested?
- JNT-517 Suspension and JNT-517 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 31 Oct 2022to 29 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parts A, B, C, and F:
- Males and females 18 to 55 years of age.
- Medically healthy with no clinically significant medical history.
- Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg (110 lbs).
- Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the study.
- Part D and E:
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- Males and females 18 to 65 years of age, inclusive.
- Diagnosis of PKU with a confirmed genotype.
- At least 2 plasma Phe levels >600 μM over the past 12 months.
- BMI of 18-40 kg/m2.
- All Parts:
- Females of childbearing potential must agree to use 2 highly effective contraceptive methods.
- Capable of giving signed informed consent and able to comply with study procedures.
Who cannot join
- All Parts:
- Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.
- Positive for hepatitis B or C or human immunodeficiency virus.
- Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer.
- Any history of liver disease.
- Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
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- Participation in another investigational drug trial within 30 days or, if known, 5 half-lives of the investigational drug (whichever is longer).
- History of drug/alcohol abuse in the last year.
- Current, recent, or suspected infection within 4 weeks of Screening of SARS-CoV-2/COVID-19.
- Received a vaccine for SARS-CoV-2/COVID-19 within 14 days of Screening.
- Unable to tolerate oral medication.
- Allergy to JNT-517 or any component of the investigational product.
- Received >50 mL of blood or plasma within 30 days of Screening or >500 mL of blood or plasma within 60 days of Screening.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States11 sites
Rare Disease Research
Atlanta, Georgia, 30329
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Florida College of Medicine
Gainesville, Florida, 32610
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Oregon Health & Sciences University
Portland, Oregon, 97239
Utah Health - The University of Utah Hospital
Salt Lake City, Utah, 84112
University of South Florida
Tampa, Florida, 33620
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Nucleus Network Melbourne
Melbourne, Melbourne VIC, 3004
Mater Misericordia Ltd
South Brisbane, Queensland, 4101
Westmead Hospital
Westmead, New South Wales, 2145
About this study
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
The goal of Parts A and B of this Phase 1/2, 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 6 parts:
Read more
- 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 2 in participants with PKU (4 weeks)-randomized, double-blind, placebo-controlled
- Part E: Phase 2 in participants with PKU (4 weeks) open label
- Part F: SAD Phase 1 in healthy participants, randomized, double-blind, placebo-controlled
In each part, participants will complete a Screening Period, a Treatment Period, and a Follow-up Period for safety.
- Conditions
- Phenylketonuria
- Being tested
- JNT-517 Suspension, Placebo Suspension, JNT-517 Tablet, Placebo Tablet
- Keywords
- PKU
- Medical subject headings
- Phenylketonurias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNT-517 SuspensionDrug
JNT-517 in on-site compounded suspension
Placebo SuspensionDrug
On-site compounded placebo suspension
JNT-517 TabletDrug
JNT-517 tablets, 25 mg and 75 mg
Placebo TabletDrug
Matching film-coated placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| JNT-517 SAD (Part A and Part F) | Experimental | Single dose of JNT-517 or placebo in fasted state. Receives: Drug: JNT-517 Suspension; Drug: Placebo Suspension |
| JNT-517 MAD (Part B) | Experimental | JNT-517 or placebo once or twice daily for 14 days, with first daily dose given after an overnight fast. Receives: Drug: JNT-517 Suspension; Drug: Placebo Suspension |
| JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C) | Experimental | Single dose of JNT-517 suspension, JNT-517 tablet in a fasted state, and JNT-517 tablet in a fed state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives. Receives: Drug: JNT-517 Suspension; Drug: JNT-517 Tablet |
| JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C) | Experimental | Single dose of JNT-517 tablet in a fasted state, JNT-517 tablet in a fed state, and JNT-517 suspension in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives. Receives: Drug: JNT-517 Suspension; Drug: JNT-517 Tablet |
| JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C) | Experimental | Single dose of JNT-517 tablet in a fed state, JNT-517 suspension, and JNT-517 tablet in a fasted state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives. Receives: Drug: JNT-517 Suspension; Drug: JNT-517 Tablet |
| JNT-517 PKU (Part D and E) | Experimental | JNT-517 or placebo daily for 4 weeks. Dose is based on data from Parts A, B, and C. Receives: Drug: JNT-517 Tablet; Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events
Reported based on results of 12-lead ECGs, vital signs, clinical laboratory tests, and other medical assessments.
Measured: Parts A/C/F: Screening to Day 8; Part B: Screening to Day 21; Part D/E: Screening to Day 35
Secondary outcomes (8)
Plasma area under the concentration-time curve (AUC) of JNT-517
Measured: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Maximum observed plasma concentration (Cmax) of JNT-517
Measured: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Time to maximum plasma concentration (Tmax) of JNT-517
Measured: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Plasma terminal half-life (t1/2) of JNT-517
Measured: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Comparison of Tmax of JNT-517 in fed and fasted states
Part C only
Measured: Pre-dose to 72 hrs post-dose on Day 1
Comparison of Cmax of JNT-517 in fed and fasted states
Part C only
Measured: Pre-dose to 72 hrs post-dose on Day 1
Comparison of AUC of JNT-517 in fed and fasted states
Part C only
Measured: Pre-dose to 72 hrs post-dose on Day 1
Changes in urinary amino acid levels
Part D/E only. Urine samples will be collected at the indicated timepoints and analyzed for amino acid levels, including Phe.
Measured: Screening and Days 1, 7, 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start31 Oct 2022
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhenylketonuriaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will be conducted in 6 parts: Parts A, B, C,D, E, and F. This study will be seamless, meaning various study parts could begin while other parts are still ongoing, but dose escalation will occur only after satisfactory review of safety and tolerability data from a minimum of 6 participants completing through Day 3, and available PK data.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781399
- Sponsor's protocol ID
- JNT517-101
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05781399
- Acronym / sponsor ID
- JNT517-101
- Conditions
- Phenylketonuria
- Keywords
- PKU
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of Parts A and B of this Phase 1/2, 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 6 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 2 in participants with PKU (4 weeks)-randomized, double-blind, placebo-controlled
- Part E: Phase 2 in participants with PKU (4 weeks) open label
- Part F: SAD Phase 1 in healthy participants, randomized, double-blind, placebo-controlled
In each part, participants will complete a Screening Period, a Treatment Period, and a Follow-up Period for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- The study will be conducted in 6 parts: Parts A, B, C,D, E, and F. This study will be seamless, meaning various study parts could begin while other parts are still ongoing, but dose escalation will occur only after satisfactory review of safety and tolerability data from a minimum of 6 participants completing through Day 3, and available PK data.
| Arm | Type | Receives |
|---|---|---|
| JNT-517 SAD (Part A and Part F) | Experimental | Drug: JNT-517 Suspension, Drug: Placebo SuspensionSingle dose of JNT-517 or placebo in fasted state. |
| JNT-517 MAD (Part B) | Experimental | Drug: JNT-517 Suspension, Drug: Placebo SuspensionJNT-517 or placebo once or twice daily for 14 days, with first daily dose given after an overnight fast. |
| JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C) | Experimental | Drug: JNT-517 Suspension, Drug: JNT-517 TabletSingle dose of JNT-517 suspension, JNT-517 tablet in a fasted state, and JNT-517 tablet in a fed state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives. |
| JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C) | Experimental | Drug: JNT-517 Suspension, Drug: JNT-517 TabletSingle dose of JNT-517 tablet in a fasted state, JNT-517 tablet in a fed state, and JNT-517 suspension in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives. |
| JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C) | Experimental | Drug: JNT-517 Suspension, Drug: JNT-517 TabletSingle dose of JNT-517 tablet in a fed state, JNT-517 suspension, and JNT-517 tablet in a fasted state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives. |
| JNT-517 PKU (Part D and E) | Experimental | Drug: JNT-517 Tablet, Drug: Placebo TabletJNT-517 or placebo daily for 4 weeks. Dose is based on data from Parts A, B, and C. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females 18 to 55 years of age.
- Medically healthy with no clinically significant medical history.
- Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg (110 lbs).
- Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the study.
- Males and females 18 to 65 years of age, inclusive.
Key exclusion criteria (13 listed)
- Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.
- Positive for hepatitis B or C or human immunodeficiency virus.
- Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer.
- Any history of liver disease.
- Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNT-517 SuspensionJNT-517 in on-site compounded suspension | Drug | JNT-517 MAD (Part B), JNT-517 SAD (Part A and Part F), JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C), JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C), JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C) |
| Placebo SuspensionOn-site compounded placebo suspension | Drug | JNT-517 MAD (Part B), JNT-517 SAD (Part A and Part F) |
| JNT-517 TabletJNT-517 tablets, 25 mg and 75 mg | Drug | JNT-517 PKU (Part D and E), JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C), JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C), JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C) |
| Placebo TabletMatching film-coated placebo tablet | Drug | JNT-517 PKU (Part D and E) |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: Parts A/C/F: Screening to Day 8; Part B: Screening to Day 21; Part D/E: Screening to Day 35
Reported based on results of 12-lead ECGs, vital signs, clinical laboratory tests, and other medical assessments.
8 secondary outcomes
Plasma area under the concentration-time curve (AUC) of JNT-517
Time frame: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Maximum observed plasma concentration (Cmax) of JNT-517
Time frame: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Time to maximum plasma concentration (Tmax) of JNT-517
Time frame: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Plasma terminal half-life (t1/2) of JNT-517
Time frame: Parts A/C/F: pre-dose to 72 hrs post-dose on Day 1; Part B: pre-dose to 24 hrs post-dose on Days 1, 14 and pre-dose on Days 3, 13; Part D/E: pre-dose to 4 hrs post-dose on Days 1, 14, 28
Comparison of Tmax of JNT-517 in fed and fasted states
Time frame: Pre-dose to 72 hrs post-dose on Day 1
Comparison of Cmax of JNT-517 in fed and fasted states
Time frame: Pre-dose to 72 hrs post-dose on Day 1
Comparison of AUC of JNT-517 in fed and fasted states
Time frame: Pre-dose to 72 hrs post-dose on Day 1
Changes in urinary amino acid levels
Time frame: Screening and Days 1, 7, 14, 21, 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JNT-517 Suspension and JNT-517 Tablet in people with Phenylketonuria, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (time frame: Parts A/C/F: Screening to Day 8; Part B: Screening to Day 21; Part D/E: Screening to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.