Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

NCT07118891 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: ABCL635-101297103
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

Vasomotor Symptoms Associated With Menopause; Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Frequency and severity of adverse events (AE)

  Day 0 to day 197

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

  Day 0 to day 197

• Number of participants with abnormalities in physical examination

  Day 0 to day 197

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

  Day 0 to day 197

Secondary Outcomes (12)

• Plasma concentrations of ABCL635

  Day 0 to day 197

• Incidence of anti-ABCL635 antibodies

  Day 0 to day 197

• PK parameters; maximum plasma concentration (Cmax)

  Day 0 to day 197

• PK parameters; time to maximum plasma concentration (Tmax)

  Day 0 to day 197

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

  Day 0 to day 197

Other Outcomes (8)

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

  up to day 141 (Part C)

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

  up to day 141 (Part C)

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

  up to day 141 (Part C)

Study Arms (7)

ABCL635 Part A

EXPERIMENTAL

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

Biological: ABCL635

Placebo Part A

PLACEBO COMPARATOR

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

Biological: Placebo

ABCL635 Part B

EXPERIMENTAL

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

Biological: ABCL635

Placebo Part B

PLACEBO COMPARATOR

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

Biological: Placebo

ABCL635 Part C

EXPERIMENTAL

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

Biological: ABCL635

Placebo Part C

PLACEBO COMPARATOR

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

Biological: Placebo

ABCL635 Part C OLE

EXPERIMENTAL

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.

Biological: ABCL635

Interventions

ABCL635 BIOLOGICAL

Participants will receive SC administrations of ABCL635

ABCL635 Part A; ABCL635 Part B; ABCL635 Part C; ABCL635 Part C OLE

Placebo BIOLOGICAL

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

Placebo Part A; Placebo Part B; Placebo Part C

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• AbCellera Biologics Inc.: lead

Study Sites (13)

CaRe Clinics

Calgary, Alberta, T2N 4L7, Canada

RECRUITING

CaRe Clinics

Red Deer, Alberta, T4P 1K4, Canada

RECRUITING

Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit

Vancouver, British Columbia, V5T 3N4, Canada

RECRUITING

Centricity Research

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Centricity Research

Toronto, Ontario, M4W 4L6, Canada

RECRUITING

Alpha Recherche Clinique

Lévis, Quebec, G6V 0C9, Canada

RECRUITING

GCP Research

Montreal, Quebec, H1Y 3H5, Canada

RECRUITING

Altasciences Company Inc.

Mount Royal, Quebec, H3P 3P1, Canada

RECRUITING

Clinique RSF Inc.

Québec, Quebec, G1V 3M8, Canada

RECRUITING

Diex Recherche Québec

Québec, Quebec, G1V 4T3, Canada

RECRUITING

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1L 0H8, Canada

RECRUITING

Diex Recherche Trois-Rivières

Trois-Rivières, Quebec, GSA 4P3, Canada

RECRUITING

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

RECRUITING

Study Officials

• Eric Sicard

  Altasciences Company Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Coordinator

CONTACT

1-877-933-9037; clinicaltrials@abcellera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 12, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)