A Phase 1 interventional study of AGA2115 and Placebo in Osteogenesis Imperfecta, sponsored by Angitia Incorporated Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Angitia Incorporated Limited · Phase 1, Interventional, and Treatment
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 72 is above the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Angitia Incorporated Limited is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts.
Drug: AGA2115
Participants will receive matching placebo.
Drug: Placebo
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.
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.
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.
Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Maximum observed concentration (Cmax) of AGA2115
Time frame: 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
Time frame: 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
Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Plan to share: No
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Ran from Oct 2023 to primary completion in Oct 2024, 12 months.
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Studies of the drug tested here: Humanized bispecific antibody neutralizing both sclerostin AND DICKKOPF-1 (AGA-2115)
Angitia Incorporated Limited