jRCT2080223785CompletedPhase 1
A phase I, randomized, double-blind, placebo-controlled, inter-individual, ascending dose, multi-site study to assess the safety, tolerability, and pharmacokinetics of AMY109 after a single subcutaneous administration in healthy volunteers and after multiple subcutaneous administrations in patients with endometriosis
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- A Single And Multiple Sc Administrations, Randomized, Double-blind, Placebo-controlled, Inter-individual, Ascending Dose, Multi-site Study
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 20age old over to 64age old under (—)
- Sex
- All
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
Outcomes
Primary Outcomes
-
safety Observation / inspection
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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