Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

AbCellera Biologics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Healthy Volunteers; Vasomotor Symptoms Associated With Menopause

Treatments: Biological: ABCL635; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07118891

297103 (Other Identifier)

ABCL635-101

Details and patient eligibility

About

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.

Full description

The study consists of 3 parts: Part A and Part B (Phase 1) and Part C (Phase 2). 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 ≤ 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:

  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, 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:

  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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

136 participants in 7 patient groups, including a placebo group

ABCL635 Part A

Experimental group

Description:

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

Treatment:

Biological: ABCL635

Placebo Part A

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

ABCL635 Part B

Experimental group

Description:

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

Treatment:

Biological: ABCL635

Placebo Part B

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

ABCL635 Part C

Experimental group

Description:

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

Treatment:

Biological: ABCL635

Placebo Part C

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

ABCL635 Part C OLE

Experimental group

Description:

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.

Treatment:

Biological: ABCL635