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

Osteogenesis Imperfecta Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086613
• Other study ID #: ACT22-002
• Status: Recruiting
• Phase: Phase 1
• Start date: October 3, 2023
• Est. completion date: October 7, 2024

Study information

• Verified date: October 2023
• Source: Angitia Biopharmaceuticals
• Contact: Elisa Dauphinee
• Phone: 818-862-2068
• Email: info[@]angitiabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 7, 2024
• Est. primary completion date: October 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Orange County Research Center	Lake Forest	California

Sponsors (1)

Lead Sponsor	Collaborator
Angitia Incorporated Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)