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

Korábbi kezelés

• Previous exposure to AGA2118 (for MAD only).
• Administration of the any medications that known to affect bone metabolism within 6 months of Day 1 unless otherwise specified (for SAD and MAD).

Más betegség

• Any condition that would affect bone metabolism or has a history of low energy fractures as documented in medical history (for MAD only).
• Human immunodeficiency virus (HIV) infection (for SAD and MAD).
• Active chronic hepatitis B (HBV) or hepatitis C (HCV) infection including hepatitis B surface antigen and hepatitis C antigen positive participants with or without abnormal liver enzymes (for SAD and MAD).

Laborértékek

• Evidence of any of the following (for SAD and MAD):
  • creatinine ≥ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m\^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at screening
  • current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range
  • known intolerance to calcium supplements
  • malignancy within the last 5 years, etc.

Egyéb

• A bone fracture within 6 months (for SAD only).

• Healthy men ≥ 30 and ≤ 65 years of age or postmenopausal women ≥ 45 and ≤ 65 years of age for SAD and MAD;
• BMI ≥ 18.5 and ≤ 32 kg/m\^2 (for SAD and MAD).
• Generally healthy (as assessed by the investigator).
• Nonsmokers, or light smokers, defined as ≤ 3 cigarettes/day (or equivalent) (for SAD and MAD).
• 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).
• 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