臨床研究等提出・公開システム

Healthy Japanese and Caucasian adults, and Japanese adult patients with chronic kidney disease Phase I Trial of AK1960

Healthy Japanese and Caucasian adults, and Japanese adult patients with chronic kidney disease Phase I Trial of AK1960

Yamaguchi Seika

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

Jan. 23, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Healthy volunteer part
- Who are able to fully understand the contents of the clinical trial and are capable of providing written consent.
- Healthy men and women (women who are not capable of becoming pregnant)
- Who do not have the 430C>T mutation and the 1075A>C mutation in the CYP2C9 gene

Patients part
- Who are able to fully understand the contents of the clinical trial and are capable of providing written consent.
- Patients diagnosed with chronic kidney disease
- Who do not have the 430C>T mutation and the 1075A>C mutation in the CYP2C9 gene

Healthy volunteer part
- 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
- 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)

Patients part
- Patients with rapidly progressing and unstable kidney disease

Both

chronic kidney disease

- Oral administration of AK1960
- Oral administration of a CYP2C9 inhibitor and AK1960

Pharmacokinetic endpoints: Pharmacokinetic parameters
Safety endpoints: Adverse events, vital signs, clinical tests
Efficacy endpoints: Urinary protein, urinary albumin

+81-3-5213-0028

No

none