Single-dose AGA2118 ethnobridging in healthy Japanese, Chinese, and Caucasian adults
A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants
This trial will test how a single dose of AGA2118 is processed and tolerated in healthy Japanese, Chinese, and Caucasian adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Angitia Biopharmaceuticals Industry-sponsored |
| Locations | 1 site (Glendale, California) |
| Trial ID | NCT07361354 on ClinicalTrials.gov |
What this trial studies
This Phase 1 ethnobridging trial tests pharmacokinetics, pharmacodynamics, and safety of AGA2118 after a single dose in healthy Japanese, Chinese, and Caucasian adults. Eighteen Japanese participants are randomized 1:1:1 to three dose levels and followed for 85 days after dosing. After the Japanese cohorts, six Caucasian participants and six Chinese participants will each receive the highest dose, with Caucasians matched to the Japanese group by sex and weight. The study collects blood samples and safety assessments to compare how the drug is processed and tolerated across the three ethnic groups.
Who should consider this trial
Good fit: Healthy adults aged 18 to 65 who meet the study's Japanese, Chinese, or Caucasian ethnicity criteria, have adequate vitamin D levels, and have no recent major medical events are eligible.
Not a fit: People who are pregnant or breastfeeding, have recent fractures, recent myocardial infarction or stroke, recent malignancy, abnormal calcium levels, or who do not meet the ethnicity criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could define appropriate dosing and safety information for AGA2118 across Japanese, Chinese, and Caucasian populations to inform future patient trials.
How similar studies have performed: Ethnobridging single-dose PK/safety studies are a common, established approach and similar early-phase trials have successfully guided dosing across ethnic groups.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glendale, California
- Los Angeles EPCU — Glendale, California, United States (Recruiting)
Study contacts
- Study coordinator: Kimberly Brown
- Email: clinicaltrials@angitiabio.com
- Phone: 818-862-2068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.