RecruitingPhase 1NCT07361354

A Phase 1 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


Sponsor

Angitia Incorporated Limited

Enrollment

30 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • Healthy males or females, aged 18 to 65 years
  • 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 Criteria6

  • 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

Interventions

DRUGAGA2118

Participants will receive AGA2118 administered by subcutaneous injection


Locations(1)

Los Angeles EPCU

Glendale, California, United States

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NCT07361354


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