NCT07361354

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Angitia Incorporated Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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 (group average matching) by sex and weight. Additionally, 6 Chinese participants will be enrolled to receive a single administration of the highest dose. These participants may be enrolled at any time.

Conditions

• Healthy Participants
• Pharmacokinetic Study

Interventions

Type	Name	Description
DRUG	AGA2118	Participants will receive AGA2118 administered by subcutaneous injection

Timeline

• Start date: 2026-01-05
• Primary completion: 2026-06-01
• Completion: 2026-11-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study