A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants
Angitia Incorporated Limited
Summary
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
Description
This Phase 1 ethnobridging 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. Eighteen Japanese participants will be enrolled and randomized 1:1:1 to one of three doses of AGA2118 to be administered at a single timepoint. Following completion of dosing of the Japanese participants, 6 Caucasian participants will be enrolled to receive the highest dose at a single timepoint. They will be matched to Japanese participants (gr…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 pre…
Interventions
- DrugAGA2118
Participants will receive AGA2118 administered by subcutaneous injection
Location
- Los Angeles EPCUGlendale, California