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

Phase 1CompletedNCT06086613

Angitia Incorporated Limited72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteogenesis Imperfecta

Interventions

AGA2115DRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Orange County Research Center

Lake Forest, California, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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