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

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: Recruiting
• Conditions: Healthy Participants; Pharmacokinetic Study
• Intervention / Treatment: Drug: AGA2118

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kimberly Brown; Phone Number: 818-862-2068; Email: clinicaltrials@angitiabio.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Recruiting
      • Los Angeles EPCU
      • Principal Investigator: Esther Yoon
      • Contact: Stephanie Gill; Phone Number: 888-228-7425; Email: study.losangeles@parexel.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

5

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)	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Angitia Incorporated Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 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): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Healthy volunteer; Ethnobridging
• 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