Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
NCT ID: NCT07118891
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
136 participants
INTERVENTIONAL
2025-06-23
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo Part C
Part C: postmenopausal women with moderate to severe VMS will receive a single dose o of placebo (dextrose 5% solution) administered by SC injection
Placebo
Participants will receive SC administration of placebo (5% dextrose solution)
ABCL635 Part C OLE
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.
ABCL635
Participants will receive SC administrations of ABCL635
ABCL635 Part A
Part A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection
ABCL635
Participants will receive SC administrations of ABCL635
Placebo Part A
Part A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
Placebo
Participants will receive SC administration of placebo (5% dextrose solution)
ABCL635 Part B
Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection
ABCL635
Participants will receive SC administrations of ABCL635
Placebo Part B
Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection
Placebo
Participants will receive SC administration of placebo (5% dextrose solution)
ABCL635 Part C
Part C: postmenopausal women with moderate to severe VMS will receive a single dose of of ABCL635 administered by SC injection
ABCL635
Participants will receive SC administrations of ABCL635
Interventions
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ABCL635
Participants will receive SC administrations of ABCL635
Placebo
Participants will receive SC administration of placebo (5% dextrose solution)
Eligibility Criteria
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Inclusion Criteria
* 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 ≤ 65 years of age OR a postmenopausal woman with or without VMS and who is ≥ 40 and ≤ 65 years of age OR a postmenopausal woman who is ≥ 40 and ≤ 65 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
* 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
* History of abnormal uterine bleeding or endometrial hyperplasia.
* Previous or current history of a malignant tumor, except for basal cell carcinoma.
* 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
* Syncope or unexplained dizziness.
* Use of any medication (hormonal, prescription, over the counter, herbal, or natural) for the treatment of hot flashes or over-the-counter products (including supplements) containing testosterone less than 28 days prior to study drug administration
40 Years
65 Years
ALL
Yes
Sponsors
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AbCellera Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Sicard
Role: PRINCIPAL_INVESTIGATOR
Altasciences Company Inc.
Locations
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Centricity Research
Toronto, Ontario, Canada
Centricity Research
Toronto, Ontario, Canada
Clinique RSF Inc.
Québec, Quebec, Canada
Altasciences Company Inc.
Mount Royal, , Canada
Diex Recherche Sherbrooke
Sherbrooke, , Canada
Diex Recherche Trois-Rivières
Trois-Rivières, , Canada
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
Vancouver, , Canada
Diex Recherche Victoriaville
Victoriaville, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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297103
Identifier Type: OTHER
Identifier Source: secondary_id
ABCL635-101
Identifier Type: -
Identifier Source: org_study_id
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