NCT06086613

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

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGA2115 in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Angitia Incorporated Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Osteogenesis Imperfecta

Interventions

Type	Name	Description
DRUG	AGA2115	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.
DRUG	Placebo	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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2023-10-17
• Last updated: 2025-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study