JPRN-jRCT2080225277
Completed
Phase 1
A Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of single and repeated doses of ART-001 in healthy Japanese male volunteers
ConditionsHealthy volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteers
- Sponsor
- ARTham Therapeutics Inc.
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male subjects who are aged between 20 and 45 years old, at the time of Informed Consent
- •2\. Subjects who agree that refraining from sexual activity or combining two or more suitable contraceptive methods in observation period
- •3\. Body Mass Index (BMI) between 18\.5 kg/m2 and 30\.0 kg/m2 (exclusive) , and with weight over 40 kg at screening
- •4\. Subjects judged healthy by the Investigator by all the examination results
- •5\. Have given written informed consent after receiving sufficient explanation upon participation in the study
Exclusion Criteria
- •1\. Have a significant complication which may affect drug evaluation, such as digestive, liver, musculoskeletal, respiratory, brain, cardiovascular, blood, tumor, endocrine, immune, nervous, psychiatric, urogenital diseases, impaired glucose tolerance
- •2\. Subjects who have complications or history of kidney disease
- •3\. Subjects who have complications or history of liver disease
- •4\. Subjects who have a history of surgical operations or medical disorders judged by the investigator that may affect the absorption, distribution, metabolism, excretion of the drug
- •5\. Subjects who used drugs or herbal medicine products within 2 weeks before the investigational drug administration or who may need such drugs
- •6\. Subjects who ingested grapefruit, oranges or apples and juice or foods containing them within 72 hours before the investigational drug administration
- •7\. Subjects who took alcohol exceeding 10 units (1 unit: beer 350 mL, wine 150 mL, distilled liquor 45 mL) per week
- •8\. Subjects who habitually ingest coffee, tea, green tea, cola, other caffeinated beverages exceeding 6 cups (1cup:150mL) per day
- •9\. Smokers or subjects who smoked or used nicotine containing products within 6 months before the screening test
- •10\. Subjects who collected 400 mL or more of blood within 12 weeks or collected 200 mL of blood within 4 weeks or donated blood component within 2 weeks before the study drug administration, or subjects who collected more than 1200 mL of blood per year
Outcomes
Primary Outcomes
Not specified
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