A First-in-Human Study Evaluating AGA2118 in Men and Postmenopausal Women

Inclusion Criteria

• •1. Healthy men ≥ 30 and ≤ 65 years of age or postmenopausal women ≥ 45 and ≤ 65 years of age for SAD and MAD;
• •2. BMI ≥ 18.5 and ≤ 32 kg/m\^2 (for SAD and MAD).
• •3. Generally healthy (as assessed by the investigator).
• •4. Nonsmokers, or light smokers, defined as ≤ 3 cigarettes/day (or equivalent) (for SAD and MAD).
• •5. Able and willing to correctly and independently complete all study procedures and able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures (for SAD and MAD).
• •6. A male who is sterile or agrees to the following during the Treatment Period and for at least 6 months after the final dose of investigational product
• •* Refrain from donating fresh unwashed semen
• •Plus, either
• •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
• •OR
• •Must agree to use contraception as detailed below
• •* Agree to use a male condom plus a female partner to use a highly effective method of contraception with a woman of childbearing potential who is not currently pregnant
• •* Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person