ABCL635 for Hot Flashes

Recruiting at 4 trial locations

Overseen By Clinical Trial Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbCellera Biologics Inc.

Must not be taking: Hormonal, Testosterone, others

Disqualifiers: Pregnancy, Malignant tumor, Cardiovascular, others

Compensation: Varies

Number of Visits: 144

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABCL635 to evaluate its effectiveness and safety for individuals experiencing hot flashes, particularly postmenopausal women. Researchers aim to understand how different doses affect symptoms like the frequency and severity of hot flashes. The trial includes several groups: healthy men and postmenopausal women, some with moderate-to-severe hot flashes and some without. A suitable candidate for this trial would be a postmenopausal woman with moderate-to-severe hot flashes that impact daily life. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

Yes, you need to stop using any medication for hot flashes or products containing testosterone at least 28 days before starting the trial.

Is there any evidence suggesting that ABCL635 is likely to be safe for humans?

Research has shown that ABCL635 is a new antibody medicine aimed at treating hot flashes without using hormones. In this early research stage, the main goal is to assess the safety and tolerability of the treatment in healthy men and postmenopausal women.

Since ABCL635 is being tested in humans for the first time, no previous safety data from past studies exists. This trial is essential for understanding how people respond to this treatment. As an early-phase trial, researchers focus on monitoring any side effects and how well participants tolerate the treatment.

If this trial finds ABCL635 to be safe, it could become a promising option for managing hot flashes during menopause. Participants in the study will help gather crucial information about the treatment's effects and any possible side effects. This information will guide future research and development of ABCL635. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike existing treatments for hot flashes, which typically involve hormone replacement therapy (HRT) or non-hormonal medications like SSRIs and gabapentin, ABCL635 offers a new approach. This investigational drug is administered via a single subcutaneous injection, which could be more convenient for patients compared to daily oral medications. Researchers are excited because ABCL635 targets the underlying mechanisms of hot flashes in a potentially novel way, offering hope for those who may not respond well to current therapies or who prefer non-hormonal options.

What evidence suggests that ABCL635 might be an effective treatment for hot flashes?

Research has shown that ABCL635, which participants in this trial may receive, is a promising new treatment for hot flashes, particularly for postmenopausal women. Unlike many current treatments that use hormones, this is a non-hormonal therapy. As an antibody medicine, ABCL635 targets specific proteins in the body linked to hot flashes. While detailed human data is still being collected, the science suggests it could effectively reduce the frequency and severity of these symptoms. Initial findings are encouraging, and more results are expected soon. ^{2 6 7 8 9}

Who Is on the Research Team?

Eric Sicard

Principal Investigator

Altasciences Company Inc.

Are You a Good Fit for This Trial?

This trial is for healthy men and postmenopausal women, with or without hot flashes. Specifically, it's for those experiencing moderate-to-severe vasomotor symptoms (VMS) due to menopause. Participants must be in good health overall.

Inclusion Criteria

My overall health is good, as confirmed by my doctor.

Body mass index (BMI) between 18.5 kg/m2 and 35.0 kg/m2

My testosterone levels are at or above 15 nmol/L.

Exclusion Criteria

I have had abnormal bleeding or thickening of the womb lining.

Pregnancy and/or lactation

Severe hypersensitivity reactions (like angioedema) to any drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Single Ascending Dose (SAD)

Single ascending doses of ABCL635 or placebo administered to healthy male and female participants

4 weeks

1 visit (in-person) per dose

Part B: Multiple Ascending Dose (MAD)

Up to 3 multiple ascending doses of ABCL635 or placebo administered to healthy postmenopausal women with or without VMS

6 weeks

1 visit (in-person) per dose

Part C: Single Dose

Single dose of ABCL635 or placebo administered to postmenopausal women experiencing moderate-to-severe VMS

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Regular assessments up to day 141

Open-label extension (optional)

Participants in Part C receiving placebo may opt into continuation of treatment with a single dose of ABCL635

1 week

What Are the Treatments Tested in This Trial?

Interventions

• ABCL635

Trial Overview The study tests ABCL635 given by subcutaneous injection compared to a placebo. It aims to assess the drug's safety, how well it's tolerated, its pharmacokinetics (how the body processes it), and pharmacodynamics (how it affects the body).

How Is the Trial Designed?

Group I: ABCL635 Part C OLE Experimental Treatment 1 Intervention

Part C open label extension (OLE): postmenopausal women with moderate to severe VMS who received placebo will receive a single dose of ABCL635 administered by SC injection upon completion of 12-week assessment.

Group II: ABCL635 Part C Experimental Treatment 1 Intervention

Part C: postmenopausal women with moderate to severe VMS will receive a single dose of of ABCL635 administered by SC injection

Group III: ABCL635 Part B Experimental Treatment 1 Intervention

Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection

Group IV: ABCL635 Part A Experimental Treatment 1 Intervention

Part A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection

Group V: Placebo Part A Placebo Group 1 Intervention

Part A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection

Group VI: Placebo Part B Placebo Group 1 Intervention

Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection

Group VII: Placebo Part C Placebo Group 1 Intervention

Part C: postmenopausal women with moderate to severe VMS will receive a single dose o of placebo (dextrose 5% solution) administered by SC injection

Who Is Running the Clinical Trial?

AbCellera Biologics Inc.

Lead Sponsor

Trials

6

Recruited

6,400+

Citations

1. investors.abcellera.com investors.abcellera.com/news/news-releases/2025/AbCellera-Reports-Q2-2025-Business-Results--First-Participants-Dosed-in-a-Phase-1-Clinical-Trial-of-ABCL635-for-Vasomotor-Symptoms/default.aspx

AbCellera Reports Q2 2025 Business Results & First ... AbCellera Reports Q2 2025 Business Results & First Participants Dosed in a Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms.

2. abcellera.com abcellera.com/pipeline/abcl635

ABCL635 ABCL635 is a potential first-in-class antibody medicine for the non-hormonal treatment of VMS (commonly known as hot flashes) associated with menopause.

3. investing.com investing.com/news/company-news/abcellera-begins-dosing-in-phase-1-trial-for-menopause-treatment-93CH-4178326

AbCellera begins dosing in phase 1 trial for menopause ... Initial safety and efficacy data are expected by mid-2026. The company also reported that a Phase 1 trial of ABCL575 for moderate-to-severe ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07118891

ABCL635 in Vasomotor Symptoms Associated With Menopause The purpose of this study is to evaluate the effects of single and multiple doses of ABCL635 administered by subcutaneous (SC) injection to ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABCL/pressreleases/33976130/abcellera-reports-q2-2025-business-results-first-participants-dosed-in-a-phase-1-clinical-trial-of-abcl635-for-vasomotor-symptoms/

AbCellera Reports Q2 2025 Business Results & First ... AbCellera Reports Q2 2025 Business Results & First Participants Dosed in a Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07118891

Study Evaluating ABCL635 for Vasomotor Symptoms of ... 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 ...

7. s21.q4cdn.com s21.q4cdn.com/223776925/files/doc_news/AbCellera-Reports-Q2-2025-Business-Results--First-Participants-Dosed-in-a-Phase-1-Clinical-Trial-of-ABCL635-for-Vasomotor-Symptoms-2025.pdf

AbCellera Reports Q2 2025 Business Results & First ... This is a randomized, placebo-controlled, double-blind Phase 1 study in healthy men and postmenopausal women with or without VMS. Its purpose is ...

8. investors.abcellera.com investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-the-Phase-1-Clinical-Trial-of-ABCL635-for-Vasomotor-Symptoms-Due-to-Menopause/default.aspx

News Releases ABCL635 is a potential first-in-class antibody medicine for the non-hormonal treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot ...

9. trialx.com trialx.com/clinical-trials/listings/317697/study-evaluating-abcl635-for-vasomotor-symptoms-of-menopause/

Study Evaluating ABCL635 for Vasomotor Symptoms of ... The safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters of ABCL635 will be assessed in all study participants; the effects on ...