RecruitingPHASE1, PHASE2INTERVENTIONAL

Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

This research study is testing a new medication called ABCL635. It's designed to help understand how this medication works and if it can relieve hot flashes and night sweats (known as vasomotor symptoms) in women going through menopause. The study has a few parts: first, looking at its effects in healthy men and women, then in healthy postmenopausal women, and finally, in postmenopausal women who are experiencing bothersome hot flashes and night sweats. Researchers will be checking for its safety, how the body handles the medication, and whether it makes symptoms better. The medication is given as an injection under the skin. The goal is to find new and effective ways to manage these common menopause symptoms.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AbCellera Biologics Inc.

Enrolment target

136

Start

23 Jun 2025

Estimated completion

01 Feb 2027

Vasomotor Symptoms Associated With Menopause Healthy Volunteers

What is this study about?

This study is exciting because it's looking into a new medicine, ABCL635, that could help women who are struggling with hot flashes and night sweats during menopause. These symptoms, often called vasomotor symptoms, can be very disruptive to daily life, sleep, and overall well-being. Finding new, effective treatments is really important for improving quality of life for many women.

The study has been carefully designed in different stages to make sure the new medicine is safe and that we understand how it works. Initially, smaller doses are given to healthy people to check for any immediate concerns and how the body handles the medicine. Then, in later stages, it focuses on postmenopausal women, especially those who are having moderate to severe hot flashes and night sweats, to see if the medicine can actually reduce these symptoms.

By participating in a study like this, you're not just helping yourself, but you're also contributing to medical knowledge that could benefit many others in the future. The information gathered will help doctors and researchers understand if ABCL635 could be a good new option for managing menopause symptoms.

Key takeaways

The study tests a new medication (ABCL635) for menopause symptoms like hot flashes.
It checks the medication's safety, how it works, and if it reduces symptoms.
Participation involves injections and health check-ups over several weeks.
You might receive the active medication or a placebo (dummy medicine).
Both healthy people and postmenopausal women with symptoms can participate.
Your involvement helps advance medical understanding of menopause treatments.

Who may be eligible?

To be considered for this study, participants generally need to be in good overall health and weigh between about 7 stone (45 kg) and 19 stone (120 kg). Your Body Mass Index (BMI) should be between 18.5 and 35. You also shouldn't be a current smoker, and if you used to smoke, you need to have stopped at least 90 days before starting the study.

Both men and women between the ages of 40 and 75 can take part in different stages of the study. For women, you need to have gone through menopause, meaning your periods have stopped for at least 12 months, or you've had certain surgeries or hormone levels that confirm menopause. You'll also need up-to-date breast cancer screening. For men, your testosterone levels need to be in a certain range, and you must agree to use birth control if you can father children, or not donate sperm during the study period.

There are also some reasons why you might not be able to join, such as if you are pregnant or breastfeeding, have certain womb lining conditions, a history of most types of cancer (excluding non-melanoma skin cancer), or a very slow heart rate. These rules are in place to keep everyone safe and ensure the study results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you generally in good health?
Are you between 40 and 75 years old?
If a woman, have your periods stopped for at least 12 months (or similar criteria)?
Are you a non-smoker, or have you quit smoking at least 3 months ago?
Do you weigh between 45 kg (about 7 stone) and 120 kg (about 19 stone)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

Taking part in this study involves several visits to the clinic over a period of time. You'll likely receive the study medication, ABCL635, or a placebo (a dummy medicine) through an injection under your skin. Depending on which part of the study you're in, you might receive a single dose or several doses over a few weeks. Researchers will regularly check your health, which could include physical exams, blood tests, and asking you about any symptoms you're experiencing, like hot flashes. The study will assess how your body handles the medicine and whether it helps with your symptoms. After the initial treatment period, some women in one part of the study might have the option to receive the active medication in an open-label extension. The total duration of your participation will depend on the specific part of the study you join, but it could involve assessments over about 12 weeks, with follow-up appointments after that.

Potential risks and benefits

Participating in a clinical trial can have potential benefits, like gaining access to a new medication before it's widely available and receiving close medical attention and monitoring from a study team. The main benefit may be contributing to medical research that could help future patients. However, there are also potential risks; you might experience side effects from the study medication, or the medication might not be effective for your symptoms. You could also receive a placebo, meaning you wouldn’t get the active treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

CaRe Clinics
Verified postcode
Calgary, Canada· Recruiting
CaRe Clinics
Verified postcode
Red Deer, Canada· Recruiting
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
Verified postcode
Vancouver, Canada· Recruiting
Centricity Research
Verified postcode
Toronto, Canada· Recruiting
Centricity Research
Verified postcode
Toronto, Canada· Recruiting
Alpha Recherche Clinique
Verified postcode
Lévis, Canada· Recruiting
GCP Research
Verified postcode
Montreal, Canada· Recruiting
Altasciences Company Inc.
Verified postcode
Mount Royal, Canada· Recruiting
Clinique RSF Inc.
Verified postcode
Québec, Canada· Recruiting
Diex Recherche Québec
Verified postcode
Québec, Canada· Recruiting
Diex Recherche Sherbrooke
Verified postcode
Sherbrooke, Canada· Recruiting
Diex Recherche Trois-Rivières
Verified postcode
Trois-Rivières, Canada· Recruiting

Common questions

What are 'vasomotor symptoms'?

Vasomotor symptoms are common menopause symptoms like hot flashes (sudden feelings of heat, often with sweating) and night sweats.

What is ABCL635?

ABCL635 is the name of the new medication being tested in this study to see if it can help with hot flashes and night sweats.

How is the medication given?

The medication, ABCL635, is given as an injection under the skin, similar to an insulin shot.

What does 'placebo' mean?

A placebo is a 'dummy' medicine that looks exactly like the active medication but contains no active drug. It helps researchers compare the effects of the real medicine.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Clinical Trial Coordinator

clinicaltrials@abcellera.com 1-877-933-9037 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.