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

July 6, 2026 updated by: Angitia Incorporated Limited

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Los Angeles EPCU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (Japanese)
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118.
Drug: AGA2118
Participants will receive AGA2118 administered by subcutaneous injection
Experimental: Cohort 2 (Japanese)
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118.
Drug: AGA2118
Participants will receive AGA2118 administered by subcutaneous injection
Experimental: Cohort 3 (Japanese)
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118.
Drug: AGA2118
Participants will receive AGA2118 administered by subcutaneous injection
Experimental: Cohort 4 (Caucasian)
Healthy Caucasian participants will receive a single administration of high dose AGA2118.
Drug: AGA2118
Participants will receive AGA2118 administered by subcutaneous injection
Experimental: Cohort 5 (Chinese)
Healthy Chinese participants will receive a single administration of high dose AGA2118.
Drug: AGA2118
Participants will receive AGA2118 administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: Day 1 to up to the end of study (85 days post-dose)
Cmax of AGA2118 after dosing
Day 1 to up to the end of study (85 days post-dose)
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
Day 1 to up to the end of study (85 days post-dose)
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
Day 1 to up to the end of study (85 days post-dose)
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
Day 1 to up to the end of study (85 days post-dose)
Clearance (CL)
Time Frame: Day 1 to up to the end of study (85 days post-dose)
CL of AGA2118 after dosing
Day 1 to up to the end of study (85 days post-dose)
Volume of distribution (Vd)
Time Frame: Day 1 to up to the end of study (85 days post-dose)
Vd of AGA2118 after dosing
Day 1 to up to the end of study (85 days post-dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to the end of study (85 days post-dose)
Occurrence of TEAEs
Baseline to the end of study (85 days post-dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angitia Incorporated Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ACT24-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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