RecruitingPhase 1NCT06938763

Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule After Oral Administration of Single and Multiple Ascending Doses to Healthy Adults


Sponsor

Academia Sinica, Taiwan

Enrollment

76 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule after Oral Administration of Single and Multiple Ascending Doses to Healthy Adults


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called J4 for the first time in healthy adults. The goal is to assess whether the drug is safe, how well it is tolerated, and how the body processes it. This is a Phase 1 safety study — participants will be closely monitored. **You may be eligible if...** - You are a healthy adult between 18 and 64 years old - Your BMI is between 18 and 30 - You have no clinically significant health conditions based on physical exams, blood tests, and heart monitoring - You are willing to use highly effective contraception during the study and for 90 days after the last dose **You may NOT be eligible if...** - You have any significant health conditions identified during screening - You are pregnant, breastfeeding, or planning to become pregnant - You are unwilling or unable to use the required contraception methods - You have a history of significant drug or alcohol use that could affect the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGJ4

dry powder capsule

DRUGPlacebo

Placebo dry powder capsule


Locations(1)

Taipei Medical University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06938763


Related Trials