Osteogenesis Imperfecta
Conditions
Brief summary
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
Interventions
DRUGAGA2115
In Part A, participants will receive AGA2115 as a single dose administered as a subcutaneous (SC) injection (5 cohorts) or as an intravenous (IV) infusion (1 cohort). In Part B, participants will receive AGA2115 in multiple doses administered as a SC injection.
DRUGPlacebo
In Part A, participants will receive single dose of placebo administered as a SC injection (5 cohorts) or IV infusion (1 cohort). In Part B, participants will receive multiple doses of placebo administered as a SC injection.
Sponsors
Angitia Incorporated Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B) | Clinically significant changes in clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) will be recorded as TEAEs. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) of AGA2115 | Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B) |
| Time to maximum observed concentration (Tmax) of AGA2115 | Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B) |
| Area under the concentration time curve (AUC) of AGA2115 | Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B) |
Countries
United States
Outcome results
None listed