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OpenTrials
Completed

NCT Number: NCT06086613

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange County Research Center

Lake Forest, California, 92630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)

    Clinically significant changes in clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) will be recorded as TEAEs.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Angitia Incorporated Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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