A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Osteogenesis Imperfecta

In brief

To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.

Key facts

Study ID

NCT06086613

Run by

Angitia Incorporated Limited

People needed

72

Starts

2023-10-03

Expected to finish

2024-10-17

Last updated by the study team

2025-01-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orange County Research Center — Lake Forest, California, United States

Full record on ClinicalTrials.gov

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