RecruitingPhase 1/2

Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Canada136 participantsStarted 2025-06-23

Plain-language 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.

Who can participate

Age range40 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)
✓. 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

What they're measuring

Frequency and severity of adverse events (AE)

Timeframe: Day 0 to day 197

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

Timeframe: Day 0 to day 197

Number of participants with abnormalities in physical examination

Timeframe: Day 0 to day 197

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

Timeframe: Day 0 to day 197

Trial details

NCT IDNCT07118891

SponsorAbCellera Biologics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Clinical Trial Coordinator

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

View on ClinicalTrials.gov More Vasomotor Symptoms Associated With Menopause trials

Plain-language summary

Who can participate

Age range40 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)
✓. 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

What they're measuring

Frequency and severity of adverse events (AE)

Timeframe: Day 0 to day 197

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

Timeframe: Day 0 to day 197

Number of participants with abnormalities in physical examination

Timeframe: Day 0 to day 197

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

Timeframe: Day 0 to day 197