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

Exclusion Criteria15

• For part 1 and part 2:
• Clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
• History of or current malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years, or cervical intraepithelial neoplasia >5 years ago that was treated and not known to have recurred).
• Current opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
• Serious local infections (e.g., cellulitis, abscess) or systemic infection (eg, septicemia) within the 3 months prior to Screening.
• History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the investigational drug
• Surgery within 3 months prior to Screening (exception is various minor procedures [e.g., mole removal, minor cosmetic procedures, or minor dental procedures]).
• Clinically relevant/significant laboratory findings at Screening (up to 1 repeat permitted) or on Day -1 (repeats not permitted) including, but not limited to: Alanine transaminase (ALT) and aspartate transaminase (AST) >1.2 × upper limit of normal (ULN); isolated and mainly unconjugated hyperbilirubinemia consistent with Gilbert's should not be excluded.
• Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening that has not resolved prior to dosing.
• Donated blood (1 unit or more) within 1 month prior to dosing or plans to donate blood during the study.
• Hormone replacement therapy (i.e., estrogen, or estrogen plus progesterone) within 3 months prior to dosing or plans to begin hormone replacement therapy at any time during the study. Local estrogen therapy for vaginal atrophy replacement is permitted.
• Systemic glucocorticoid therapy for more than 1 month within 6 months before Screening.
• Changes in medications that may affect muscle function (e.g., high intensity statins, beta-blockers) within 3 months prior to dosing. Dose to remain stable while on study.
• History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to Screening.
• Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month or 5 half-lives prior to dosing.