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

April 3, 2024 updated by: Angitia Incorporated Limited

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive matching placebo.
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.
Experimental: AGA2115

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angitia Incorporated Limited

Investigators

  • Study Director: Angitia Medical Director, Angitia Incorporated Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2023

Primary Completion (Estimated)

October 7, 2024

Study Completion (Estimated)

October 7, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT22-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteogenesis Imperfecta

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe