Phase
Condition
Healthy Volunteers
Treatment
ABCL635
Placebo
Clinical Study ID
Ages 40-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Good general health as determined through a review of their medical history andafter 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 usingnicotine 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 apostmenopausal woman with or without VMS and who is ≥ 40 and ≤ 75 years of age OR apostmenopausal woman who is ≥ 40 and ≤ 75 years of age seeking treatment for relieffor VMS
If a woman:
has been compliant with local and/or national guidelines for breast cancerscreening with documentation of a mammogram with normal/negative or noclinically significant findings. A screening mammogram may be conducted duringstudy screening period, if needed
has spontaneous amenorrhea for at least 12 consecutive months; or spontaneousamenorrhea 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 toscreening and meeting the biochemical criteria of menopause (FSH > 40 IU/L)
- 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 andnot to donate sperm from the first study drug administration to at least 90days after the last drug administration OR is unable to procreate; defined assurgically sterile
Exclusion
Exclusion Criteria:
Pregnancy and/or lactation.
Has endometrial hyperplasia or history of abnormal uterine bleeding without anidentified cause in the past 6 months
Previous or current history of a malignant tumor, except for non-melanoma skincancer.
Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or aseated 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, ordermatologic 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 testosteroneor any medication (hormonal, prescription, over the counter, herbal, or natural) forthe 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 aredirectly involved in the conduct of the study
Study Design
Study Description
Connect with a study center
CaRe Clinics
Calgary, Alberta T2N 4L7
CanadaActive - Recruiting
CaRe Clinics
Red Deer, Alberta T4P 1K4
CanadaActive - Recruiting
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
Vancouver, British Columbia V5T 3N4
CanadaActive - Recruiting
Centricity Research
Toronto, Ontario M4W 4L6
CanadaActive - Recruiting
Centricity Research
Toronto 6167865, Ontario 6093943 M4W 4L6
CanadaSite Not Available
Alpha Recherche Clinique
Lévis, Quebec G6V 0C9
CanadaActive - Recruiting
GCP Research
Montreal, Quebec H1Y 3H5
CanadaActive - Recruiting
Altasciences Company Inc.
Mount Royal, Quebec H3P 3P1
CanadaActive - Recruiting
Altasciences Company Inc.
Mount-Royal, Quebec H3P 3P1
CanadaSite Not Available
Clinique RSF Inc.
Québec, Quebec G1V 3M8
CanadaActive - Recruiting
Diex Recherche Québec
Québec, Quebec G1V 4T3
CanadaActive - Recruiting
Diex Recherche Sherbrooke
Sherbrooke, Quebec J1L 0H8
CanadaActive - Recruiting
Diex Recherche Trois-Rivières
Trois-Rivières, Quebec GSA 4P3
CanadaActive - Recruiting
Diex Recherche Victoriaville
Victoriaville, Quebec G6P 3Z8
CanadaActive - Recruiting
Clinique RSF Inc.
Québec 6325494, Quebec 6115047 G1V 3M8
CanadaSite Not Available
Diex Recherche Sherbrooke
Sherbrooke 6146143, Quebec 6115047 J1L 0H8
CanadaSite Not Available
Diex Recherche Trois-Rivières
Trois-Rivières 6169141, Quebec 6115047 GSA 4P3
CanadaSite Not Available
Diex Recherche Victoriaville
Victoriaville 6174151, Quebec 6115047 G6P 3Z8
CanadaSite Not Available
Altasciences Company Inc.
Mount Royal 6077315,
CanadaSite Not Available
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
Vancouver 6173331,
CanadaSite Not Available

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