Safety and pharmacology of AMY109, a long-acting anti-interleukin-8 antibody, for endometriosis: a double-blind, randomized phase 1 trial.

ABSTRACT:

Objective

To evaluate the safety and pharmacokinetics/pharmacodynamics of AMY109, an anti-interleukin-8 recycling antibody in a first-in-human phase 1 trial in healthy volunteers (HVs) and patients with endometriosis.

Design

A multicenter, randomized, double-blind, placebo-controlled single-dose and multiple ascending-dose study in Japan and Taiwan.

Subjects

Asian and White HVs in part 1 and patients with endometriosis aged ≥20 to <50 years in part 2.

Intervention

In part 1, sequential cohorts of HVs randomly received a single subcutaneous dose of AMY109 (0.6, 2.0, 3.5, or 5.0 mg/kg) or placebo. In part 2, sequential cohorts of patients with endometriosis randomly received a once-monthly subcutaneous dose of AMY109 (0.8, 2.0, or 5.0 mg/kg) or placebo for 6 mont

SUBMITTER: Wang PH 

PROVIDER: S-EPMC12496429 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature