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

• Status: Recruiting
• Trial end date: 2024-10-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Angitia Incorporated Limited

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.