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Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

NCT07118891 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Vasomotor Symptoms Associated With Menopause
  • Healthy Volunteers

Interventions

BIOLOGICAL

ABCL635

Participants will receive SC administrations of ABCL635

BIOLOGICAL

Placebo

Participants will receive SC administration of placebo (5% dextrose solution)

Sponsors & Collaborators

  • AbCellera Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard · Altasciences Company Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118891 on ClinicalTrials.gov