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

Phase

Condition

Musculoskeletal Diseases

Severe Short Stature

Bone Diseases

Treatment

Placebo

AGA2115

Clinical Study ID

NCT06086613

ACT22-002

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 VitaminD supplements during the trial.

Exclusion

Exclusion Criteria:

History of myocardial infarction or stroke (or other cardiovascular associated eventdeemed significant by investigator) within 12 months prior to Day 1.
Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinomathat 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 anytime during the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Design