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Study Summary
This trial studies safety, tolerability, & PK of oral JNT-517 in healthy participants & effect on PKU. It's 4 parts, each w/ screening, treatment & follow-up safety periods.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- 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.
- Group 1: JNT-517 SAD (Part A)
- Group 2: JNT-517 MAD (Part B)
- Group 3: JNT-517 PKU (Part D)
- Group 4: JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C)
- Group 5: JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C)
- Group 6: JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C)
- 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.
Frequently Asked Questions
Is it feasible for me to join this experiment?
"Eligibility criteria for this research necessitates that participants have phenylketonuria and span the ages of 18 to 65. As of now, 112 individuals are being enrolled into this clinical trial."
Are individuals being accepted into this clinical experiment at present?
"Clinicaltrials.gov displays that this clinical trial is currently seeking participants, with its original post date being October 31st 2022 and the latest update occurring on May 30th 2023."
What is the current enrollment size of this research endeavor?
"Affirmative. According to the information found on clinicaltrials.gov, this examination is in the process of recruiting volunteers and was first published on October 31st 2022. As of May 30th 2023, there are 112 individuals sought from 2 clinics."
Is this research endeavor open to those aged 55 and above?
"This study has a specific age range requirement of between 18 to 65 years old. Separately, there are 12 studies for those under the age of consent and another dozen trials available for people over the age of 65."
Has the FDA granted authorization to JNT-517 SAD (Part A)?
"The safety of JNT-517 SAD (Part A) was assessed as a 1 on Power's scale due to the relative scarcity of data available about its efficacy and security."
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