Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Last updated: May 12, 2026
Sponsor: AbCellera Biologics Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Healthy Volunteers

Treatment

ABCL635

Placebo

Clinical Study ID

NCT07118891
ABCL635-101
297103
  • Ages 40-75
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Good general health as determined through a review of their medical history andafter conducting a general physical examination

  • Body weight ≥ 45 to ≤ 120 kg

  • Body mass index (BMI) between 18.5 kg/m2 and 35.0 kg/m2

  • Non- or ex-smoker (an ex-smoker is defined as someone who completely stopped usingnicotine products for at least 90 days prior to the first study drug administration)

  • Healthy man or a postmenopausal woman who is ≥ 40 and ≤ 75 years of age OR apostmenopausal woman with or without VMS and who is ≥ 40 and ≤ 75 years of age OR apostmenopausal woman who is ≥ 40 and ≤ 75 years of age seeking treatment for relieffor VMS

  • If a woman:

  1. has been compliant with local and/or national guidelines for breast cancerscreening with documentation of a mammogram with normal/negative or noclinically significant findings. A screening mammogram may be conducted duringstudy screening period, if needed

  2. has spontaneous amenorrhea for at least 12 consecutive months; or spontaneousamenorrhea for at least 6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] > 40 IU/L); or had a bilateral oophorectomy > 6 weeks prior to screening, or s/p hysterectomy at least 6 weeks prior toscreening and meeting the biochemical criteria of menopause (FSH > 40 IU/L)

  • If a man:
  1. possess a testosterone concentration of ≥ 15 nmol/L at the time of screening

  2. can procreate and agree to use one of the acceptable contraceptive regimens andnot to donate sperm from the first study drug administration to at least 90days after the last drug administration OR is unable to procreate; defined assurgically sterile

Exclusion

Exclusion Criteria:

  • Pregnancy and/or lactation.

  • Has endometrial hyperplasia or history of abnormal uterine bleeding without anidentified cause in the past 6 months

  • Previous or current history of a malignant tumor, except for non-melanoma skincancer.

  • Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or aseated blood pressure < 90/50 mmHg or > 140/90 mmHg

  • eGFR < 60 mL/min/1.73 m2

  • Severe hypersensitivity reactions (like angioedema) to any drugs.

  • Significant uncontrolled cardiovascular, pulmonary, gastrointestinal, hepatic,renal, hematologic, neurological, psychiatric, endocrine, immunologic, ordermatologic disease.

  • Clinically significant ECG abnormalities

  • Presence or history of cardiogenic syncope in the past 6 months.

  • Use of any over-the-counter products (including supplements) containing testosteroneor any medication (hormonal, prescription, over the counter, herbal, or natural) forthe treatment of hot flashes during the screening period and throughout the study;must be discontinued at least 28 days prior to study drug administration

  • Employees of the sponsor or the investigator site and other individuals who aredirectly involved in the conduct of the study

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: ABCL635
Phase: 1/2
Study Start date:
June 23, 2025
Estimated Completion Date:
February 28, 2027

Study 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. In Part C, all participants 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.

Connect with a study center

  • CaRe Clinics

    Calgary, Alberta T2N 4L7
    Canada

    Active - Recruiting

  • CaRe Clinics

    Red Deer, Alberta T4P 1K4
    Canada

    Active - Recruiting

  • Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit

    Vancouver, British Columbia V5T 3N4
    Canada

    Active - Recruiting

  • Centricity Research

    Toronto, Ontario M4W 4L6
    Canada

    Active - Recruiting

  • Centricity Research

    Toronto 6167865, Ontario 6093943 M4W 4L6
    Canada

    Site Not Available

  • Alpha Recherche Clinique

    Lévis, Quebec G6V 0C9
    Canada

    Active - Recruiting

  • GCP Research

    Montreal, Quebec H1Y 3H5
    Canada

    Active - Recruiting

  • Altasciences Company Inc.

    Mount Royal, Quebec H3P 3P1
    Canada

    Active - Recruiting

  • Altasciences Company Inc.

    Mount-Royal, Quebec H3P 3P1
    Canada

    Site Not Available

  • Clinique RSF Inc.

    Québec, Quebec G1V 3M8
    Canada

    Active - Recruiting

  • Diex Recherche Québec

    Québec, Quebec G1V 4T3
    Canada

    Active - Recruiting

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec J1L 0H8
    Canada

    Active - Recruiting

  • Diex Recherche Trois-Rivières

    Trois-Rivières, Quebec GSA 4P3
    Canada

    Active - Recruiting

  • Diex Recherche Victoriaville

    Victoriaville, Quebec G6P 3Z8
    Canada

    Active - Recruiting

  • Clinique RSF Inc.

    Québec 6325494, Quebec 6115047 G1V 3M8
    Canada

    Site Not Available

  • Diex Recherche Sherbrooke

    Sherbrooke 6146143, Quebec 6115047 J1L 0H8
    Canada

    Site Not Available

  • Diex Recherche Trois-Rivières

    Trois-Rivières 6169141, Quebec 6115047 GSA 4P3
    Canada

    Site Not Available

  • Diex Recherche Victoriaville

    Victoriaville 6174151, Quebec 6115047 G6P 3Z8
    Canada

    Site Not Available

  • Altasciences Company Inc.

    Mount Royal 6077315,
    Canada

    Site Not Available

  • Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit

    Vancouver 6173331,
    Canada

    Site Not Available

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