A Phase 1 Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)

NCT07361354 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ACT24-006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetic Study; Healthy Participants

Keywords

Ethnobridging; Healthy volunteer

Outcome Measures

Primary Outcomes (6)

• Maximum concentration (Cmax)

  Cmax of AGA2118 after dosing

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

• Time to maximum concentration (Tmax)

  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)

  AUC of AGA2118 after dosing

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

• Half-life (t1/2)

  t1/2 of AGA2118 after dosing

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

• Clearance (CL)

  CL of AGA2118 after dosing

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

• Volume of distribution (Vd)

  Vd of AGA2118 after dosing

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

Secondary Outcomes (1)

• Treatment-emergent adverse events (TEAEs)

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

Study Arms (5)

Cohort 1 (Japanese)

EXPERIMENTAL

One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118.

Drug: AGA2118

Cohort 2 (Japanese)

EXPERIMENTAL

One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118.

Drug: AGA2118

Cohort 3 (Japanese)

EXPERIMENTAL

One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118.

Drug: AGA2118

Cohort 4 (Caucasian)

EXPERIMENTAL

Healthy Caucasian participants will receive a single administration of high dose AGA2118.

Drug: AGA2118

Cohort 5 (Chinese)

EXPERIMENTAL

Healthy Chinese participants will receive a single administration of high dose AGA2118.

Drug: AGA2118

Interventions

AGA2118 DRUG

Participants will receive AGA2118 administered by subcutaneous injection

Cohort 1 (Japanese); Cohort 2 (Japanese); Cohort 3 (Japanese); Cohort 4 (Caucasian); Cohort 5 (Chinese)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angitia Incorporated Limited: lead

Study Sites (1)

Los Angeles EPCU

Glendale, California, 91206, United States

RECRUITING

Central Study Contacts

Kimberly Brown

CONTACT

818-862-2068; clinicaltrials@angitiabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)