A RELATIVE AND ABSOLUTE BIOAVAILABILITY STUDY OF AMY109 WITH HEALTHY MALE VOLUNTEERS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220046

Enrollment

Registered

2022-08-27

Start date

2022-10-07

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

Endometriosis

Interventions

AMY109 is administered subcutaneously at the prescribed dose. AMY109 is administered intravenously at the prescribed dose.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Written informed consent must be obtained from the subject. Body mass index (BMI) between 18.5 and < 30.0 kg/m2 at screening.

Exclusion criteria

Exclusion criteria: Subject with cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, or pulmonary disease. History of malignancy or leukemia within 10 years before screening.

Design outcomes

Primary

Measure	Time frame
Safety, Bioavailability, Phamacokinetics Adverse Events and Adverse Drug Reactions Vital Signs 12 lead ECG Laboratory Values Plasma AMY 109 concentration and pharmacokinetic parameters	—

Secondary

Measure	Time frame
Other Anti-AMY109 antibody in plasma	—

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

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