A phase I study to assess the safety, tolerability, and pharmacokinetics of AMY109

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223785

Enrollment

100

Registered

2018-01-25

Start date

2018-02-26

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 volunteers and patients with endometriosis

Interventions

investigational material(s) Generic name etc : AMY109 INN of investigational material : - Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [Healthy male volunteers] - Aged => 20 and 20 and 20 and < 50 years - Patient has a moderate to severe pain for endometriosis for the screening period

Exclusion criteria

Exclusion criteria: - Any clinically significant abnormalities at the screening tests - History of hypersensitivity associated with antibody preparations and additive or excipients of AMY109

Design outcomes

Primary

Measure	Time frame
safety Observation / inspection	—

Secondary

Measure	Time frame
pharmacokinetics Observation / inspection	—

Countries

Asia exept Japan, Japan

Outcome results

None listed

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