A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of KER-012 Administered to Healthy, Postmenopausal Women

INTERVENTION: KER‐012 will be administered subcutaneously. Intervention adherence will be assessed by study monitors, this will be done by audit of nurses notes and pharmacy logs The study consists of two parts: Single Ascending Dose: 4 cohorts of 10 participants randomized 4 (study drug): 1 (placebo) Cohort 1: 0.75 mg/kg single subcutaneous on day 1 Cohort 2: TBD* mg/kg on single subcutaneous on day 1 Cohort 3: TBD* mg/kg on single subcutaneous on day 1 Cohort 4: TBD* mg/kg on single subcutaneous on day 1 (*the doses for subsequent cohorts will be based on the Safety Review Committee (SRC) recommendation after review of pharmacokinetic and safety data from cohort 1) Multiple Ascending Dose: 4 cohorts of 10 participants randomized 4 (study drug): 1 (placebo) Cohort 1: TBD* mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57 Cohort 2: TBD* mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57 Cohort 3: TBD* mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57 Cohort 4: TBD* mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57 (*specified dose levels and frequency to be confirmed following review of safety and pharmacokinetics data from part 1(SAD) and based on data it is anticipated that three cohorts will receive every 4‐week (Q4W) dosing and one cohort will explore every 2‐week dosing (Q2) CONDITION: Cardiovascular ‐ Hypertension Healthy Postmenopausal Women; ; Healthy Postmenopausal Women Musculoskeletal ‐ Osteoporosis Musculoskeletal ‐ Other muscular and skeletal disorders PRIMARY OUTCOME: Part 1/ Part 2: To evaluate the safety and tolerability of escalating doses of KER‐012 administered as single and multiple SC doses in healthy postmenopausal women.; To be assessed by monitoring; • Incidence and severity of adverse events (AE);; • Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;; • Clinically significant changes from baseline in:; ‐ Laboratory evaluations (hematology, chemistry, urinalysis, function tests);; ‐ Electrocardiograms (ECG);; ‐ Vital signs;; ‐ Physical examinations;; ‐ Anti‐drug antibodies[Part 1/ Part 2: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57 ; Part 2 (every four weeks; Q4W): From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 28, Day 29, Day 36, Day 43, Day 50, Day 56, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 ; Part 2 (every two weeks; Q2W): From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 14, Day 15, Day 22, Day 28, Day 29, Day 36, Day 42, Day 43, Day 50, Day 56, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 ] SECONDARY OUTCOME: Part 1/ Part 2: To assess the pharmacodynamic effect on bone tissue following escalating doses of KER‐012 administered as single and multiple SC doses ; In Part 1 and Part 2 of this study, the pharmacodynamic effect will be assessed based on change from baseline in biomarkers of bone growth and resorption ; ; [Part 1: Day 1, Day 5, Day 7, Day 15, Day 22, Day 29, Day 43, Day 57 post intervention administration ; Part 2 (every four weeks; Q4W): Day 1, Day 7, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 63, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration ; Part 2 (every two weeks; Q2W): Day 1, Day 7, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 63, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration ; The dual‐energy X‐ray absorptiometry (DXA) assessment is to be conducted within 7 days of dosing (not as part of the initial Screening visit)] Part 1/ Part 2: To assess the pharmacodynamic effect on follicle‐stimulating hormone (FSH) following escalating doses of KER‐012 administered as single and multiple SC doses as assessed in change from baseline[Part 1: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57 post intervention administration ; Part 2 (every four weeks or every two weeks): From baseline to Day 1, Day 2, Day 3, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration ; ; ] Part 1/ Part 2: To evaluate the pharmacokinetic profile following escalating doses of KER‐012 administered as single and multiple SC doses ; The following parameters will be used for pharmacokinetic assessment: Maximum concentration (Cmax), Time to maximum concentration (tmax), Area under the concentration‐time curve from time 0 to last (AUC0‐last), Area under the concentration‐time curve from time 0 to infinity (AUC0‐inf), Terminal elimination half‐life (t1/2), Apparent clearance (CL/F), Apparent volume of distribution (Vz/F), Minimum concentration (Ctrough), Area under the concentration‐time curve over the dosing interval AUC (0‐tau), Accumulation ratio (Rac).[Part 1: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57 post intervention administration ; Part 2 (every four weeks; Q4W): From baseline to Day 1, Day 2, Day 3, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration ; Part 2 (every two weeks; Q2W): From baseline to Day 1, Day 2, Day 3, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration] Part 2: To assess the pharmacodynamic effect on bone tissue following escalating doses of KER‐012 administered as single and multiple SC doses ; The pharmacodynamic effect will be assessed based on change from baseline in lean body mass, fat mass, and bone mineral density (BMD) using total body scan by dual‐energy X‐ray absorptiometry (DXA).[Part 2 (every four weeks; Q4W or every two weeks; Q2W): From baseline to Day 56, Day 113 post intervention administration ; The dual‐energy X‐ray absorptiometry (DXA) assessment is to be conducted within 7 days of dosing (not as part of the initial Screening visit)] INCLUSION CRITERIA: For part 1 and part 2: 1. Postmenopausal female, aged 45 to 70 years (inclusive) at Screening. NOTE: Postmenopausal is defined as: 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with serum follicle‐stimulating hormone (FSH) levels >40 IU/L or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 2. Non‐smoker or social smoker who agrees to smoke <=8 cigarettes per week or is willing to abstain from smoking/nicotine products during the study including the follow‐up period. 3. Body mass index of >18.5 kg/m2 to <32 kg/m2 at Screening. 4. In good health as determined by review of medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, 12‐lead electrocardiogram (ECG), and any abnormal findings that are assessed as not clinically significant by the Investigator.