Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Not Applicable

Recruiting

• Conditions: Vasomotor Symptoms Associated With Menopause; Healthy Volunteers
• Interventions: Biological: ABCL635; Biological: Placebo

• Registration Number: NCT07118891
• Lead Sponsor: AbCellera Biologics Inc.

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.

Detailed Description

The study consists of 3 parts. 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. Part C participants receiving placebo 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.

Study Timeline

• Study Start: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-15
• Primary Completion: 2027-02
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 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 ≤ 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

• Pregnancy and/or lactation.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABCL635 Part A	ABCL635	Part A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection
Placebo Part A	Placebo	Part A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
Placebo Part B	Placebo	Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection
ABCL635 Part C	ABCL635	Part C: postmenopausal women with moderate to severe VMS will receive a single dose of of ABCL635 administered by SC injection
Placebo Part C	Placebo	Part C: postmenopausal women with moderate to severe VMS will receive a single dose o of placebo (dextrose 5% solution) administered by SC injection
ABCL635 Part B	ABCL635	Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection
ABCL635 Part C OLE	ABCL635	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.

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events (AE)	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
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

Secondary Outcome Measures

Name	Time	Method
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
PK parameters; terminal rate constant (λz)	Day 0 to day 197
PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)	Day 0 to day 197
PK parameters; apparent volume of distribution after extravascular administration (Vz/F)	Day 0 to day 197
Plasma concentrations of ABCL635	Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)	Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)	Day 0 to day 197
PK parameters; percent of AUC obtained by extrapolation (%AUCextrap)	Day 0 to day 197
PK parameters; half-life (Thalf)	Day 0 to day 197

Trial Locations

Locations (1)

Altasciences Company Inc.; 🇨🇦 Mount-Royal, Quebec, Canada