Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

What this trial studies

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 in scope

• Vasomotor Symptoms Associated With Menopause
• Healthy Volunteers

Interventions

• ABCL635 (Biological) — Participants will receive SC administrations of ABCL635
• Placebo (Biological) — Participants will receive SC administration of placebo (5% dextrose solution)

Who can join

All sexes · Ages 40 Years to 75 Years · Accepts healthy volunteers.

Inclusion criteria

• Good general health as determined through a review of their medical history and after 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 using nicotine 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 a postmenopausal woman with or without VMS and who is ≥ 40 and ≤ 75 years of age OR a postmenopausal woman who is ≥ 40 and ≤ 75 years of age seeking treatment for relief for VMS
• If a woman:
• has been compliant with local and/or national guidelines for breast cancer screening with documentation of a mammogram with normal/negative or no clinically significant findings. A screening mammogram may be conducted during study screening period, if needed
• has spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea 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 to screening and meeting the biochemical criteria of menopause (FSH \> 40 IU/L)

Exclusion criteria

• Pregnancy and/or lactation.
• Has endometrial hyperplasia or history of abnormal uterine bleeding without an identified cause in the past 6 months
• Previous or current history of a malignant tumor, except for non-melanoma skin cancer.
• Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or a seated 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, or dermatologic disease.
• Clinically significant ECG abnormalities

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 13 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE1, PHASE2
• Start date: 2025-06-23
• Primary completion: 2027-02
• Last update posted: 2026-04-29
• First posted: 2025-08-12

Sponsor & contact

Lead sponsor: AbCellera Biologics Inc. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Frequency and severity of adverse events (AE) (Day 0 to day 197)
• Number of participants with abnormalities in 12-lead safety electrocardiograms (ECG) (Day 0 to day 197)
• Number of participants with abnormalities in physical examination (Day 0 to day 197)
• Number of participants with abnormalities in laboratory parameters, including general biochemistry, hematology, endocrinology, and urinalysis (Day 0 to day 197)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.