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To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGA2115 | Experimental | In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGA2115 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Clinically significant changes in clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) will be recorded as TEAEs. | Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Angitia Medical Director | Angitia Incorporated Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Drug | 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. |
|
| 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) |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |