Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Trial Parameters
Brief 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 Criteria
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 mo