Recruiting

ABCL635 for Moderate-to-Severe Vasomotor Symptoms in Postmenopausal Women

Study Aim

This study aims to evaluate the safety and tolerability of ABCL635 in postmenopausal women experiencing moderate-to-severe vasomotor symptoms, by monitoring the frequency and severity of adverse events, abnormalities in ECG, laboratory parameters, and physical examinations.

What is being tested

ABCL635

+ Placebo

Biological

Who is being recruted

From 40 to 65 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2

Interventional

Study Start: June 2025

See protocol details

Summary

Principal SponsorAbCellera Biologics Inc.

Study ContactClinical Trial Coordinator

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 23, 2025

Actual date on which the first participant was enrolled.

This study is focused on testing a new drug called ABCL635 in both healthy individuals and postmenopausal women who experience moderate to severe vasomotor symptoms (VMS), which are often referred to as hot flashes or night sweats. The goal is to determine the safety and effectiveness of ABCL635 in alleviating these symptoms associated with menopause. The study is important because it aims to find a potential new treatment option for women suffering from these disruptive symptoms, improving their quality of life. The study includes postmenopausal women, both with and without VMS, to gather comprehensive data about the drug's effects. Participants in the study will receive ABCL635 or a placebo, which is a substance with no active drug, either in single or multiple doses. Healthy male and female participants will receive single doses, while postmenopausal women may receive up to three doses. The study is conducted in phases: some will get single or multiple doses, and others who don't initially receive the drug might have a chance to do so later. The study will carefully assess the drug's impact on participants' symptoms and monitor any side effects to ensure the treatment is safe. This data will help determine the drug's potential as a viable treatment option for managing menopause-related symptoms.

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

NCT07118891

Principal SponsorAbCellera Biologics Inc.

Study ContactClinical Trial Coordinator

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

136 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

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

If a woman, 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

If a man, possess a testosterone concentration of ≥ 15 nmol/L at the time of screening

If a man, 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

Show More Criteria

10 exclusion criteria prevent from participating

eGFR < 60 mL/min/1.73 m2

Clinically significant ECG abnormalities

Syncope or unexplained dizziness.

Pregnancy and/or lactation.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

42.857% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

In this group, healthy men and women will get a one-time dose of ABCL635 through a subcutaneous (under the skin) injection.

Group II

Experimental

This group is for healthy postmenopausal women, with or without certain symptoms, who will receive up to 3 doses of ABCL635 via an injection under the skin.

Group III

Experimental

Women beyond menopause with moderate to severe hot flashes will get a one-time ABCL635 injection under the skin.

Group IV

Experimental

Women who initially received a placebo will now get a single dose of ABCL635 via skin injection, after their 12-week assessment.

Group 5

Placebo

In this group, healthy men and women will receive a one-time injection of a harmless substance called placebo (a 5% dextrose solution).

Group 6

Placebo

In this group, healthy postmenopausal women, with or without VMS, will receive up to 3 doses of a placebo. This placebo is a 5% dextrose solution, given through a subcutaneous (SC) injection.

Group 7

Placebo

Women in this group will receive a single dose of placebo, a harmless sugar solution, injected under the skin.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Recruiting

Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit

Vancouver, CanadaOpen Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit in Google Maps

Recruiting

Centricity Research

Toronto, Canada

Recruiting

Centricity Research

Toronto, Canada

Recruiting

Altasciences Company Inc.

Mount Royal, Canada

Recruiting

8 Study Centers