A First-in-Human Phase 1 Study of ABCL635 in Healthy Participants and in Postmenopausal Women With Moderate-to-Severe Vasomotor Symptoms

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: t
View:

• 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:

‣ 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

• 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

Locations
Other Locations
Canada
Altasciences Company Inc.
RECRUITING
Mount Royal
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
RECRUITING
Vancouver
Contact Information
Primary
Clinical Trial Coordinator
clinicaltrials@abcellera.com
1-877-933-9037
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2027-02
Participants
Target number of participants: 136
Treatments
Experimental: ABCL635 Part A
Part A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection
Placebo_comparator: Placebo Part A
Part A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
Experimental: ABCL635 Part B
Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection
Placebo_comparator: 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
Experimental: ABCL635 Part C
Part C: postmenopausal women with moderate to severe VMS will receive a single dose of of ABCL635 administered by SC injection
Placebo_comparator: 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
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: AbCellera Biologics Inc.

This content was sourced from clinicaltrials.gov

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