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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07361354

Acronym

ATLAS

Enrollment

Registered

2026-01-23

Start date

2026-01-05

Completion date

2026-09-05

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants, Pharmacokinetic Study

Keywords

Ethnobridging, Healthy volunteer

Brief summary

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

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.

Interventions

DRUGAGA2118

Participants will receive AGA2118 administered by subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 pregnant during the study

Design outcomes

Primary

Measure	Time frame	Description
Maximum concentration (Cmax)	Day 1 to up to the end of study (85 days post-dose)	Cmax of AGA2118 after dosing
Time to maximum concentration (Tmax)	Day 1 to up to the end of study (85 days post-dose)	Tmax of AGA2118 after dosing
Area under the concentration-time curve (AUC)	Day 1 to up to the end of study (85 days post-dose)	AUC of AGA2118 after dosing
Half-life (t1/2)	Day 1 to up to the end of study (85 days post-dose)	t1/2 of AGA2118 after dosing
Clearance (CL)	Day 1 to up to the end of study (85 days post-dose)	CL of AGA2118 after dosing
Volume of distribution (Vd)	Day 1 to up to the end of study (85 days post-dose)	Vd of AGA2118 after dosing

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026