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

NCT ID: NCT06086613

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-10-17

Brief Summary

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

Conditions

Osteogenesis Imperfecta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AGA2115

In Part A, up to 6 single ascending dose cohorts.

In Part B, up to 3 multiple ascending dose cohorts.

Group Type: EXPERIMENTAL

AGA2115

Intervention Type: DRUG

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.

Placebo

Participants will receive matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Angitia Incorporated Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angitia Medical Director

Role: STUDY_DIRECTOR

Angitia Incorporated Limited

Locations

Orange County Research Center

Lake Forest, California, United States

Countries

United States

Other Identifiers

ACT22-002

Identifier Type: -

Identifier Source: org_study_id