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ABCL635 for menopausal hot flashes

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

Phase1; Phase2 Interventional AbCellera Biologics Inc. · NCT07118891

This trial will test whether one or more injected doses of ABCL635 can reduce hot flashes in postmenopausal women while checking safety and how the drug acts in healthy volunteers.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment136 (estimated)
Ages40 Years to 75 Years
SexAll
SponsorAbCellera Biologics Inc. Industry-sponsored
Locations13 sites (Calgary, Alberta and 12 other locations)
Trial IDNCT07118891 on ClinicalTrials.gov

What this trial studies

The study has three parts: Part A (single ascending doses) and Part B (multiple ascending doses) enrolling healthy men and postmenopausal women, and Part C (single dose) enrolling postmenopausal women with moderate-to-severe vasomotor symptoms. Participants will receive subcutaneous ABCL635 or placebo and will be monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics. Frequency and severity of hot flashes will be measured in the symptomatic postmenopausal group, and placebo recipients in Part C may enter an open-label extension to receive ABCL635 after 12 weeks. The protocol is an early-phase (Phase 1/2) dose-escalation design intended to characterize dosing and biological effects.

Who should consider this trial

Good fit: Ideal candidates are healthy adults and postmenopausal women aged 40–75, including those with moderate-to-severe vasomotor symptoms, who meet health and BMI criteria and can attend visits at the Canadian study sites.

Not a fit: People seeking immediate hormone therapy, those outside the 40–75 age range, or individuals with medical exclusions for early-phase trials are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ABCL635 could provide a new nonhormonal option that reduces the frequency and severity of menopausal hot flashes.

How similar studies have performed: Some nonhormonal therapies have shown benefit for vasomotor symptoms in other trials, but ABCL635 is a novel investigational agent with limited prior human efficacy data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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:

  1. 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
  2. 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)
* 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 and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration OR is unable to procreate; defined as surgically sterile

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
* Presence or history of cardiogenic syncope in the past 6 months.
* Use of any over-the-counter products (including supplements) containing testosterone or any medication (hormonal, prescription, over the counter, herbal, or natural) for the 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 are directly involved in the conduct of the study

Where this trial is running

Calgary, Alberta and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Vasomotor Symptoms Associated With MenopauseHealthy Volunteers
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.