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

NCT06086613 | Completed Phase 1 FDA Drug

• 1 other identifier: ACT22-002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

AGA2115

EXPERIMENTAL

In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts.

Drug: AGA2115

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo.

Drug: Placebo

Interventions

AGA2115 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.

AGA2115

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angitia Incorporated Limited: lead

Study Sites (1)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angitia Medical Director

  Angitia Incorporated Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 3, 2023
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: January 10, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)