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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All Parts: Females of childbearing potential must agree to use 2 highly effective contraceptive methods
Parts A, B, and C: Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg (110 lbs)
Must not have
All Parts: Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer
All Parts: Current, recent, or suspected infection within 4 weeks of Screening of SARS-CoV-2/COVID-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening and days 1, 7, 14, 21, 28
Awards & highlights
Summary
This trial tests a new oral medication, JNT-517, for safety and tolerance. It involves healthy participants and people with phenylketonuria (PKU). Researchers aim to see if JNT-517 can safely reduce certain amino acids in people with PKU.
Who is the study for?
This trial is for healthy adults aged 18-55, and those with phenylketonuria (PKU) aged 18-65. Healthy participants must not smoke and have a BMI of 18-40 kg/m2. Women should agree to use two forms of contraception. PKU patients need a confirmed diagnosis and at least two plasma Phe levels >600 μM in the past year.
What is being tested?
The study tests JNT-517's safety, tolerability, dosage effects, and impact on urinary Phe in healthy individuals and those with PKU across four parts: single & multiple dose studies, bioavailability comparison between tablet/suspension forms with food effect analysis in healthy volunteers, and a placebo-controlled test in PKU patients.
What are the potential side effects?
Potential side effects are not detailed here but will be monitored throughout the trial phases focusing on any adverse reactions from taking JNT-517 or placebo as well as its overall tolerability during different dosing regimens.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use two effective birth control methods if I can have children.
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My BMI is between 18-40 and I weigh more than 110 lbs.
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I have been diagnosed with PKU and my genetic test confirms it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had any cancer except for non-melanoma skin cancer in the last 5 years.
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I haven't had COVID-19 or suspected COVID-19 in the last 4 weeks.
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I have a history of liver disease.
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I cannot take medicine by mouth.
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I am positive for hepatitis B, C, or HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening and days 1, 7, 14, 21, 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening and days 1, 7, 14, 21, 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-emergent adverse events
Secondary study objectives
Changes in urinary amino acid levels
Comparison of AUC of JNT-517 in fed and fasted states
Comparison of Cmax of JNT-517 in fed and fasted states
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C)Experimental Treatment2 Interventions
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.
Group II: JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C)Experimental Treatment2 Interventions
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.
Group III: JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C)Experimental Treatment2 Interventions
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.
Group IV: JNT-517 SAD (Part A)Experimental Treatment2 Interventions
Single dose of JNT-517 or placebo in fasted state.
Group V: JNT-517 PKU (Part D)Experimental Treatment2 Interventions
JNT-517 or placebo daily for 4 weeks. Dose is based on data from Parts A, B, and C.
Group VI: JNT-517 MAD (Part B)Experimental Treatment2 Interventions
JNT-517 or placebo once or twice daily for 14 days, with first daily dose given after an overnight fast.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Tablet
2016
Completed Phase 3
~3690
Placebo Suspension
2014
Completed Phase 1
~110
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Phenylketonuria (PKU) treatments primarily focus on reducing phenylalanine levels in the blood to prevent neurotoxic effects. The most common treatments include a strict low-phenylalanine diet and the use of medical foods or supplements that provide essential nutrients without phenylalanine.
Additionally, enzyme substitution therapy with phenylalanine ammonia-lyase (PAL) can help break down phenylalanine. Emerging treatments like JNT-517 potentially modulate phenylalanine metabolism, offering a pharmacological approach to manage phenylalanine levels more effectively.
These treatments are vital for PKU patients to prevent cognitive impairment and other neurological issues associated with high phenylalanine levels.
Quantitative phosphoproteomics to resolve the cellular responses to octanoic acid in rotenone exposed zebrafish.Modulation of a recombinant glycine transporter (GLYT1b) by activation of protein kinase C.Propionic Acid and Fasudil as Treatment Against Rotenone Toxicity in an In Vitro Model of Parkinson's Disease.
Quantitative phosphoproteomics to resolve the cellular responses to octanoic acid in rotenone exposed zebrafish.Modulation of a recombinant glycine transporter (GLYT1b) by activation of protein kinase C.Propionic Acid and Fasudil as Treatment Against Rotenone Toxicity in an In Vitro Model of Parkinson's Disease.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Jnana TherapeuticsLead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 18 and 40.I am between 18 and 55 years old.I agree to use two effective birth control methods if I can have children.My BMI is between 18-40 and I weigh more than 110 lbs.I don't have conditions that affect how drugs work in my body.I have not had any cancer except for non-melanoma skin cancer in the last 5 years.I have not received a COVID-19 vaccine in the last 14 days.I haven't smoked for at least 2 weeks and will not smoke during the study.You have had at least 2 blood tests in the past year showing high levels of a substance called phenylalanine.I am generally healthy with no major medical issues.You have received a large amount of blood or plasma in the past few weeks.I have been diagnosed with PKU and my genetic test confirms it.I can sign the consent form and follow the study's procedures.I am between 18 and 65 years old.I haven't had COVID-19 or suspected COVID-19 in the last 4 weeks.I have a history of liver disease.I cannot take medicine by mouth.I am positive for hepatitis B, C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: JNT-517 SAD (Part A)
- Group 2: JNT-517 MAD (Part B)
- Group 3: JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C)
- Group 4: JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C)
- Group 5: JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C)
- Group 6: JNT-517 PKU (Part D)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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