Actively Recruiting

Phase 1
Phase 2
Age: 40Years - 75Years
All Genders
Healthy Volunteers
NCT07118891

Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Led by AbCellera Biologics Inc. · Updated on 2026-05-14

136

Participants Needed

13

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Good general health confirmed by medical history and physical exam
  • Body weight between 45 and 120 kg
  • Body mass index (BMI) between 18.5 and 35.0 kg/m2
  • Non-smoker or ex-smoker who quit at least 90 days before first drug dose
  • Healthy man or postmenopausal woman aged 40 to 75 years
  • Postmenopausal women must have spontaneous amenorrhea for at least 12 months, or at least 6 months with menopause hormone confirmation, or have had bilateral oophorectomy or hysterectomy with menopause hormone confirmation
  • Women must follow breast cancer screening guidelines with a normal or no significant mammogram result
  • Men must have testosterone levels of 15 nmol/L or higher at screening
  • Men who can father children must agree to use contraception and avoid sperm donation during the study and for 90 days after last drug dose, or be surgically sterile
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Endometrial hyperplasia or recent unexplained abnormal uterine bleeding
  • History or current malignant tumors except non-melanoma skin cancer
  • Low or high resting pulse rate (<50 or >100 bpm) or abnormal blood pressure (<90/50 mmHg or >140/90 mmHg)
  • Reduced kidney function (eGFR < 60 mL/min/1.73 m2)
  • Severe allergic reactions to drugs
  • Significant uncontrolled diseases including cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic conditions
  • Significant ECG abnormalities
  • History of cardiogenic syncope in past 6 months
  • Use of testosterone or hot flash treatments within 28 days before study and during study
  • Employment with the study sponsor or investigator site or direct involvement in the study conduct

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

CaRe Clinics

Calgary, Alberta, Canada, T2N 4L7

Actively Recruiting

2

CaRe Clinics

Red Deer, Alberta, Canada, T4P 1K4

Actively Recruiting

3

Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit

Vancouver, British Columbia, Canada, V5T 3N4

Actively Recruiting

4

Centricity Research

Toronto, Ontario, Canada, M4G 3E8

Actively Recruiting

5

Centricity Research

Toronto, Ontario, Canada, M4W 4L6

Actively Recruiting

6

Alpha Recherche Clinique

Lévis, Quebec, Canada, G6V 0C9

Actively Recruiting

7

GCP Research

Montreal, Quebec, Canada, H1Y 3H5

Actively Recruiting

8

Altasciences Company Inc.

Mount Royal, Quebec, Canada, H3P 3P1

Actively Recruiting

9

Clinique RSF Inc.

Québec, Quebec, Canada, G1V 3M8

Actively Recruiting

10

Diex Recherche Québec

Québec, Quebec, Canada, G1V 4T3

Actively Recruiting

11

Diex Recherche Sherbrooke

Sherbrooke, Quebec, Canada, J1L 0H8

Actively Recruiting

12

Diex Recherche Trois-Rivières

Trois-Rivières, Quebec, Canada, GSA 4P3

Actively Recruiting

13

Diex Recherche Victoriaville

Victoriaville, Quebec, Canada, G6P 3Z8

Actively Recruiting

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Research Team

C

Clinical Trial Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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