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Completed

NCT Number: NCT07361354

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

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

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Key information

Conditions

Healthy Participants Pharmacokinetic Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Los Angeles EPCU

Glendale, California, 91206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGA2118

Drug

Participants will receive AGA2118 administered by subcutaneous injection

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Day 1 to up to the end of study (85 days post-dose)

    Cmax of AGA2118 after dosing

  2. Time to maximum concentration (Tmax)

    Time frame: Day 1 to up to the end of study (85 days post-dose)

    Tmax of AGA2118 after dosing

  3. Area under the concentration-time curve (AUC)

    Time frame: Day 1 to up to the end of study (85 days post-dose)

    AUC of AGA2118 after dosing

  4. Half-life (t1/2)

    Time frame: Day 1 to up to the end of study (85 days post-dose)

    t1/2 of AGA2118 after dosing

  5. Clearance (CL)

    Time frame: Day 1 to up to the end of study (85 days post-dose)

    CL of AGA2118 after dosing

  6. Volume of distribution (Vd)

    Time frame: Day 1 to up to the end of study (85 days post-dose)

    Vd of AGA2118 after dosing

Secondary outcomes

  1. Treatment-emergent adverse events (TEAEs)

    Time frame: Baseline to the end of study (85 days post-dose)

    Occurrence of TEAEs

Sponsors and collaborators

Lead sponsor

Angitia Incorporated Limited

Industry

Registry information

Official study title

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

Acronym: ATLAS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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