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

Phase 1

Completed

• Conditions: Osteogenesis Imperfecta
• Interventions: Drug: Placebo; Drug: AGA2115

• Registration Number: NCT06086613
• Lead Sponsor: Angitia Incorporated Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-03
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-17
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive matching placebo.
AGA2115	AGA2115	In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

Orange County Research Center; 🇺🇸 Lake Forest, California, United States