Actively Recruiting
Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults
Led by Academia Sinica, Taiwan · Updated on 2026-01-06
76
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female subjects between 18 and 64 years of age at the time of consent
- Body mass index (BMI) between 18.0 and 30.0 kg/m2; males must weigh at least 50 kg, females at least 45 kg
- No clinically significant abnormalities in medical history, physical exam, vital signs, ECG, and lab tests
- Males with female partners of childbearing potential must be sterile, use effective contraception from Day -1 until 90 days after last dose, or abstain from intercourse during this period
- Males must agree to refrain from sperm donation and females from ova donation from Day -1 until 90 days after last dose
- Females of childbearing potential must be sterile or use effective contraception starting 30 days before dosing through 90 days after last dose, or abstain during this period
- Postmenopausal females must have been amenorrheic for at least 2 years or 12 months with high FSH levels
- Provide signed informed consent and be able to comply with study requirements and communicate with investigators
You will not qualify if you...
- Pregnant or breastfeeding females or those with a positive pregnancy test at screening or prior to dosing
- History of significant medical illnesses including neurological, cardiovascular, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic, renal disease, or cancer within past 5 years
- Clinically significant ECG abnormalities at screening
- Blood pressure outside 90-140 mm Hg systolic or 50-90 mm Hg diastolic at screening
- History of cardiovascular diseases such as arrhythmia, hypertension, hypotension, angina, myocardial infarction, or heart failure
- Liver or kidney dysfunction indicated by lab values exceeding specified thresholds
- Acute illness or infection within 14 days before Day -1
- Recent gastrointestinal disease or surgery affecting drug absorption
- Major surgery within 4 weeks prior to dosing
- Recent significant blood or plasma donation
- Inability to tolerate oral medication or venous access
- Use of tobacco or nicotine products within 6 months
- Daily caffeine intake over 200 mg in past 6 months
- Alcohol consumption over 1 drink daily in past 6 months
- Drug or alcohol abuse within 6 months
- History of significant drug allergy
- Positive blood tests for HCV, HBV, or HIV
- Positive urine drug or alcohol screen
- Use of investigational drugs within 4 weeks
- Use of prescription, over-the-counter, herbal, or dietary supplements within 2 weeks or 5 half-lives before dosing
- Receipt of protein or antibody therapies within 3 months
- Flu or SARS-CoV-2 vaccination within 4 weeks prior to dosing
- Use of hormonal contraceptives within 14 days prior to dosing
- Specific suicidal ideation or behavior history as assessed by C-SSRS
- Any other investigator judgment preventing participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
C
Ching-Pang Chang, Academia Sinica, Taiwan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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