A phase I study to assess the safety, tolerability, and pharmacokinetics of AMY109
Phase 1
Completed
- Conditions
- Healthy volunteers and patients with endometriosis
- Registration Number
- JPRN-jRCT2080223785
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
It was suggested that AMY109 has acceptable safety profile in single dose subcutaneous administration for healthy subjects, and multiple dose subcutaneous administration for patients with endometriosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
[Healthy male volunteers]
- Aged => 20 and < 55 years
[Healthy female volunteers]
- Non-child bearing potential or pre-menopausal aged => 20 and < 65 years
[Patients with endometriosis]
- Aged => 20 and < 50 years
- Patient has a moderate to severe pain for endometriosis for the screening period
Exclusion Criteria
- Any clinically significant abnormalities at the screening tests
- History of hypersensitivity associated with antibody preparations and additive or excipients of AMY109
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method