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

Last updated: January 8, 2025
Sponsor: Angitia Incorporated Limited
Overall Status: Completed

Phase

1

Condition

Connective Tissue Diseases

Musculoskeletal Diseases

Bone Neoplasm

Treatment

Placebo

AGA2115

Clinical Study ID

NCT06086613
ACT22-002
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 VitaminD supplements during the trial.

Exclusion

Exclusion Criteria:

  • History of myocardial infarction or stroke (or other cardiovascular associated eventdeemed significant by investigator) within 12 months prior to Day 1.

  • Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinomathat 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 anytime during the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 03, 2023
Estimated Completion Date:
October 17, 2024

Connect with a study center

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

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