NCT07118891

Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

A First-in-Human Phase 1/2 Study of ABCL635 in Healthy Participants and in Postmenopausal Women With Moderate-to-Severe Vasomotor Symptoms

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: AbCellera Biologics Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of single and multiple doses of ABCL635 administered by subcutaneous (SC) injection to healthy men and to postmenopausal women with or without any vasomotor symptoms (VMS) or hot flashes, and to postmenopausal women with moderate-to-severe VMS associated with menopause. The safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters of ABCL635 will be assessed in all study participants; the effects on frequency and severity of VMS will be assessed in postmenopausal women who experience moderate-to-severe symptoms.

Detailed description

The study consists of 3 parts: Part A and Part B (Phase 1) and Part C (Phase 2). In Part A, single ascending doses (SAD) of ABCL635 or placebo will be administered to healthy male and female participants. In Part B, up to 3 multiple ascending doses (MAD) of ABCL635 or placebo will be administered to healthy postmenopausal women with or without VMS. In Part C, a single dose of ABCL635 or placebo will be administered to postmenopausal women experiencing moderate-to-severe VMS associated with menopause. Part C participants receiving placebo will be offered to participate in an open label extension (OLE) cohort and receive a single dose of ABCL635 upon completion of a 12-week assessment.

Conditions

• Vasomotor Symptoms Associated With Menopause
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	ABCL635	Participants will receive SC administrations of ABCL635
BIOLOGICAL	Placebo	Participants will receive SC administration of placebo (5% dextrose solution)

Timeline

• Start date: 2025-06-23
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-08-12
• Last updated: 2026-04-02

Locations

10 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study