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

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

Study Overview

• Status: Completed
• Conditions: Osteogenesis Imperfecta
• Intervention / Treatment: Drug: AGA2115; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive matching placebo.	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.
Experimental: AGA2115; In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Angitia Incorporated Limited
• Investigators: Study Director: Angitia Medical Director, Angitia Incorporated Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): October 17, 2024
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Collagen Diseases; Osteogenesis Imperfecta
• Other Study ID Numbers: ACT22-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No