Actively Recruiting
A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants
Led by Angitia Incorporated Limited · Updated on 2026-01-23
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of a single dose of AGA2118 in healthy Japanese, Chinese, and Caucasian adults aged 18 to 65 years. It is a Phase 1 ethnobridging trial designed to evaluate how the drug is processed and acts in the body (pharmacokinetics and pharmacodynamics), along with its safety in these different ethnic groups. The goal is to understand any differences in drug behavior among these populations. Participants will receive a single subcutaneous injection of AGA2118. Eighteen Japanese participants will be randomly assigned to receive one of three different doses to assess dose effects. After completing the Japanese dosing groups, six Caucasian and six Chinese participants will each receive the highest dose. The Caucasian group is matched to the Japanese participants by sex and weight. Participants will be followed for 85 days after dosing to monitor effects and safety. Throughout the 85-day study period, participants will have their blood sampled to measure drug levels and how the body processes the drug, including concentration peaks, clearance, and half-life. Safety will be assessed by monitoring any adverse events from baseline through the end of the study. This includes checking vitamin D levels and requiring calcium and vitamin D supplementation during the study. The total participation time is approximately three months, during which participants' health and response to AGA2118 will be closely monitored.
CONDITIONS
Brief Title
A Phase 1 Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18 to 65 years
- Have 25-hydroxyvitamin D level of at least 30 ng/mL and agree to take calcium and vitamin D supplements during the study
- Meet the criteria for Japanese, Chinese, or Caucasian ethnicity
You will not qualify if you...
- Participated in another clinical trial within the past 6 months
- Had any bone fracture within the past 6 months
- History of heart attack or stroke within the past 12 months
- Had malignancy within the past 5 years
- Have current high or low calcium levels (hyper- or hypocalcemia)
- Pregnant or breastfeeding women, or women planning to become pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single subcutaneous injection of AGA2118 at one of three doses depending on their cohort assignment.
1 dosing visit (in-person)
Duration - 85 days post-dose
Participants are followed for safety and pharmacokinetic assessments after dosing.
Multiple visits over 85 days post-dose
Trial Site Locations
Total: 1 location
1
Los Angeles EPCU
Glendale, California, United States, 91206
Actively Recruiting
Research Team
K
Kimberly Brown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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