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Vasomotor Symptoms Associated With MenopausePhase 1/2NCT07118891

Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

A Phase 1/2 study testing ABCL635 in people with Vasomotor Symptoms Associated With Menopause and Healthy Volunteers, run by AbCellera Biologics Inc. at 13 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
What is being tested?
ABCL635
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
13 sitesCanada
Study dates
23 Jun 2025to Feb 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites

  • CaRe Clinics

    Calgary, Alberta, T2N 4L7

  • Alpha Recherche Clinique

    Lévis, Quebec, G6V 0C9

  • GCP Research

    Montreal, Quebec, H1Y 3H5

  • Altasciences Company Inc.

    Mount Royal, Quebec, H3P 3P1

  • Clinique RSF Inc.

    Québec, Quebec, G1V 3M8

  • Diex Recherche Québec

    Québec, Quebec, G1V 4T3

  • CaRe Clinics

    Red Deer, Alberta, T4P 1K4

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L 0H8

  • Centricity Research

    Toronto, Ontario, M4G 3E8

  • Centricity Research

    Toronto, Ontario, M4W 4L6

  • Diex Recherche Trois-Rivières

    Trois-Rivières, Quebec, GSA 4P3

  • Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit

    Vancouver, British Columbia, V5T 3N4

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

About this study

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

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.

Read the detailed 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.

Being tested
ABCL635, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABCL635Biological

    Participants will receive SC administrations of ABCL635

  • PlaceboBiological

    Participants will receive SC administration of placebo (5% dextrose solution)

Study groups in NCT07118891
Study groupRoleWhat they receive
ABCL635 Part AExperimentalPart A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection
Receives: Biological: ABCL635
Placebo Part APlacebo comparatorPart A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
Receives: Biological: Placebo
ABCL635 Part BExperimentalPart B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection
Receives: Biological: ABCL635
Placebo Part BPlacebo comparatorPart B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection
Receives: Biological: Placebo
ABCL635 Part CExperimentalPart C: postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection
Receives: Biological: ABCL635
Placebo Part CPlacebo comparatorPart C: postmenopausal women with moderate to severe VMS will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
Receives: Biological: Placebo
ABCL635 Part C OLEExperimentalPart C open label extension (OLE): postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection upon completion of 12-week assessment.
Receives: Biological: ABCL635

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of adverse events (AE)

    Measured: Day 0 to day 197

  2. Number of participants with abnormalities in 12-lead safety electrocardiograms (ECG)

    Measured: Day 0 to day 197

  3. Number of participants with abnormalities in physical examination

    Measured: Day 0 to day 197

  4. Number of participants with abnormalities in laboratory parameters, including general biochemistry, hematology, endocrinology, and urinalysis

    Measured: Day 0 to day 197

Secondary outcomes (20)

  1. Mean change from baseline to each study week in the frequency of moderate and severe VMS (VMSM-S frequency)

    Measured: up to day 141 (Part C)

  2. Mean change from baseline to each study week in the severity of moderate and severe VMS (VMSM-S severity)

    Measured: up to day 141 (Part C)

  3. Mean change from baseline to each study week in the frequency of all reported VMS (VMSTotal frequency).

    Measured: up to day 141 (Part C)

  4. Mean change from baseline to each study week in the moderate to severe hot flash score (HFM-S).

    The moderate to severe hot flash score (HFM-S) is a metric that combines the frequency and severity of hot flashes:

    • The daily score is calculated as follows: (number of moderate hot flashes x 2) + (number of severe hot flashes x 3)
    • The weekly score is the average daily score over seven days. A negative change in the score from Baseline to Week 1 indicates a reduction in the severity and frequency of hot flashes

    Measured: up to day 141 (Part C)

  5. Mean change from baseline to each study week in the total hot flash score (HFTotal).

    The total hot flash score (HFTotal) is a metric that combines the frequency and severity of hot flashes:

    • The daily score is calculated as follows: (number of mild hot flashes x 1) + (number of moderate hot flashes x 2) + (number of severe hot flashes x 3)
    • The weekly score is the average daily score over seven days. A negative change in the score from Baseline to Week 1 indicates a reduction in the severity and frequency of hot flashes.

    Measured: up to day 141 (Part C)

  6. Mean change in the Menopause-Specific Quality of Life Questionnaire (MENQOL) 4-domain scores (ie, physical, vasomotor, psychosocial, and sexual) from baseline to weeks 1, 2, 3, 4, 5, 9, and 13

    The Mean change in the Menopause-Specific Quality of Life Questionnaire (MENQOL) measures the impact of menopause symptoms over the last week.

    The questionnaire has 29 items across four domains: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale.

    The mean change in the MENQOL domain scores will be assessed from Baseline to each week measured. A negative change in the score from Baseline to each week measured indicates an improvement in quality of life.

    Measured: up to day 141 (Part C)

  7. Mean change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form (PROMIS-SD-SF-8b) total score from baseline to weeks 1, 2, 3, 4, 5, 9, and 13.

    The PROMIS-SD-SF-8b assesses the perception of sleep quality, sleep depth, and any perceived difficulties related to getting and staying asleep. Questions are scored using the following scale: 1 (very much), 2 (quite a bit), 3 (somewhat), 4 (a little bit), and 5 (not at all).

    The mean change in the PROMIS-SD-SF-8b score will be assessed from Baseline to each week measured. A positive change in the score from Baseline to each week measured indicates a reduction in sleep disturbance.

    Measured: up to day 141 (Part C)

  8. Frequency of Patient Global Impression of Change in VMS (PGI-C VMS) responses at weeks 2, 3, 4, 5, 9, and 13.

    The Patient Global Impression of Change (PGI-C) for vasomotor symptoms (VMS) rates the perception of their hot flashes and night sweats at each designated timepoint compared to the start of the study. The response is a seven-point scale ranging from "much better" to "much worse." The frequency of each PGI-C VMS score will be reported at each scheduled timepoint.

    Measured: up to day 141 (Part C)

  9. Plasma concentrations of ABCL635

    Measured: Day 0 to day 197

  10. Incidence of anti-ABCL635 antibodies

    Measured: Day 0 to day 197

  11. PK parameters; maximum plasma concentration (Cmax)

    Measured: Day 0 to day 197

  12. PK parameters; time to maximum plasma concentration (Tmax)

    Measured: Day 0 to day 197

  13. PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)

    Measured: Day 0 to day 197

  14. PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)

    Measured: Day 0 to day 197

  15. PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)

    Measured: Day 0 to day 197

  16. PK parameters; percent of AUC obtained by extrapolation (%AUCextrap)

    Measured: Day 0 to day 197

  17. PK parameters; terminal rate constant (λz)

    Measured: Day 0 to day 197

  18. PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)

    Measured: Day 0 to day 197

  19. PK parameters; apparent volume of distribution after extravascular administration (Vz/F)

    Measured: Day 0 to day 197

  20. PK parameters; half-life (Thalf)

    Measured: Day 0 to day 197

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start23 Jun 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118891
Sponsor's protocol ID
ABCL635-101
Other IDs
297103
Status last verified
Jul 2025
First submitted
16 Jul 2025
Last updated
15 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABCL635 in people with Vasomotor Symptoms Associated With Menopause and Healthy Volunteers, run by AbCellera Biologics Inc. at 13 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of adverse events (AE) (time frame: Day 0 to day 197). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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