臨床研究等提出・公開システム

Phase I Study of AK1940 in Healthy Japanese Subjects and Healthy Caucasian Subjects (Single Dose and Multiple Dose Study)

Phase I Study of AK1940 in Healthy Japanese Subjects and Healthy Caucasian Subjects (Single Dose and Multiple Dose Study)

Shimizu Tomohito

ASAHI KASEI THERAPEUTICS CORPORATION

1-1-2 Yurakucho, Chiyoda-ku, Tokyo

ct-info@om.asahi-kasei.co.jp

Contact for Clinical Trial Information

ASAHI KASEI THERAPEUTICS CORPORATION

1-1-2 Yurakucho, Chiyoda-ku, Tokyo

+81-3-6699-3600

ct-info@om.asahi-kasei.co.jp

Recruiting

April. 20, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Japanese healthy men and women or Caucasian healthy men
- Individuals >=18 to <45 years of age at the time of informed consent
- Individuals who fully understand the details of the study and who are capable of providing written informed consent

- Subjects with clinical abnormalities in laboratory tests, vital signs, or fixed 12-lead electrocardiogram (ECG)
- Subjects under 50.0 kg in men, less than 45.0 kg in women (in some parts: less than 50.0 kg)
- Subjects with a BM of 1 (Japanese men: less than 18.5 kg/m2 or greater than 25.0 kg/m2; Japanese women: less than 17.5 kg/m2 or greater than 25.0 kg/m2; Caucasian: less than 18.5 kg/m2 or greater than 30.0 kg/m2)

Both

Healthy Volunteer

Single or repeated subcutaneous administration of AK1940 or placebo

Pharmacokinetic endpoints: Pharmacokinetic parameters
Safety endpoints: Adverse events, vital signs, clinical tests, ECG test

+81-92-283-7701

No

none