A Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of single and repeated doses of ART-001 in healthy Japanese male volunteers
ART-001 Phase 1 study
Jan. 15, 2021
No
version:
date:
ARTham Therapeutics Inc.
24-8, Yamashita-cho, Naka-ku, Yokohama Kanagawa
+81-45-225-8858
art-001-101@arthamther.com
ARTham Therapeutics Inc.
24-8, Yamashita-cho, Naka-ku, Yokohama Kanagawa
+81-45-225-8858
art-001-101@arthamther.com
completed
Aug. 14, 2020
32
Interventional
Double blind, Randomized, Placebo comparison
other
1
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
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
11. Participation in a clinical trial of an investigational drug within 4 months or of an approved drug within 3 months before the first drug administration
12. Have surgical operations for 4 weeks before screening tests
13. Subjects with a history of severe or multiple allergies (including latex allergy), or with a history of hypersensitivity reaction to drugs
14. Have a history of drug or alcohol abuse
15. Subjects with significant electrocardiogram abnormalities, including QTcF> 450 msec in screening tests
16. Positive for immunological test (HBs antigen, HCV antibody, HIV, syphilis)
17. Considered unfit for the study by the investigator
20age old over
45age old under
Male
Healthy volunteers
investigational material(s)
Generic name etc : ART-001
INN of investigational material : -
Therapeutic category code : 29- Other agents affecting individual organs
Dosage and Administration for Investigational material : Part I (single dose)
step 1: 50 mg, step 2: 100 mg, step 3: 200 mg, step 4: 400 mg, step 5: 800 mg, step 6: Dosage confirmed to be safe from part 1-5.
Part II (QD, 7 daily dose)
group C,D: Two doses confirmed to be safe from part I.
group D: More than double dose for group C.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
safety
Part I
To evaluate the safety and tolerability of single doses of ART-001 in healthy Japanese volunteers
Part II
To evaluate the safety and tolerability of repeated doses of ART-001 in healthy Japanese volunteers
exploratory
pharmacokinetics
Part I
Pharmacokinetics of single doses of ART-001 in healthy Japanese volunteers
Influence of diet for pharmcokinetics of single dose of ART-001
Part II
Pharmacokinetics of repeated doses of ART-001 in healthy Japanese volunteers
ARTham Therapeutics Inc.
-
ARTham Therapeutics Inc.
-
Hakata Clinic Institutional Review Board
6-18, Tenyamachi, Hakata-ku Fukuoka 812-0025, Japan
