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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)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071250141
Enrollment
89
Registered
2026-03-16
Start date
2026-04-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Interventions

Single or repeated subcutaneous administration of AK1940 or placebo

Sponsors

Shimizu Tomohito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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)

Design outcomes

Primary

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

Contacts

Public ContactContact for Clinical Trial Information

ASAHI KASEI THERAPEUTICS CORPORATION

ct-info@om.asahi-kasei.co.jp+81-3-6699-3600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026