Status:
COMPLETED
A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers
Lead Sponsor:
Angitia Incorporated Limited
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
Eligibility Criteria
Inclusion
- Healthy men and women ≥18 to ≤65 years old.
- Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.
Exclusion
- History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1.
- Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
- Hyper- or hypocalcemia.
- Known sensitivity to mammalian-derived drug preparations and/or any biologics.
- Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06086613
Start Date
October 3 2023
End Date
October 17 2024
Last Update
January 10 2025
Active Locations (1)
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1
Orange County Research Center
Lake Forest, California, United States, 92630