An Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)

A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants

This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants

This Phase 1 ethnobriding study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants. Participants will be administered AGA2118 at the start of the study and followed for 85 days.

Inclusion Criteria:

• Healthy males or females, aged 18 to 65 years
• 25-hydroxyvitamin D ≥30 ng/mL and agree to taking calcium and vitamin D supplements during the study
• Meet the criteria for Japanese, Chinese, or Caucasian ethnicity

Exclusion Criteria:

• Participating or have participated in another clinical trial within the past 6 months
• Any bone fracture within the past 6 months
• History of myocardial infarction or stroke within the past 12 months
• Malignancy within the past 5 years
• Current hyper- or hypocalcemia
• Pregnant or breastfeeding women, or women planning to become pregnant during the study