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Monoclonal Antibodies

AGA2115 for Osteogenesis Imperfecta

Phase 1

Recruiting

Research Sponsored by Angitia Incorporated Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part C: Male and female adults ≥18 to ≤25 years old and adolescents ≥12 to ≤17 years old with a clinical diagnosis of OI Type I (mild) with a defect in COL1A1 and/or COL1A2, as confirmed by genetic testing.

Parts A and B: Healthy men and women ≥18 to ≤65 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b)

Awards & highlights

Study Summary

This trial tests the safety and tolerability of a new drug for healthy adults and those with Osteogenesis Imperfecta.

Who is the study for?

This trial is for healthy adults aged 18-65, and individuals aged 12-25 with mild Osteogenesis Imperfecta (OI) confirmed by genetic testing. Participants must have sufficient Vitamin D levels and agree to take supplements during the trial. Exclusions include recent severe cardiovascular events, certain cancers within the last 5 years, calcium level disorders, sensitivity to biologics, pregnancy or breastfeeding.Check my eligibility

What is being tested?

The study is evaluating AGA2115's safety and tolerability in healthy volunteers as well as those with OI when administered in single or multiple doses. The comparison will be made against a placebo to determine any differences in response between the two groups.See study design

What are the potential side effects?

While specific side effects of AGA2115 are not listed here, common side effects from similar trials may include reactions at the injection site, general discomfort or pain, potential allergic reactions due to sensitivity to mammalian-derived drug preparations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 12-25 years old with mild Osteogenesis Imperfecta Type I, confirmed by genetic tests.

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I am a healthy adult between 18 and 65 years old.

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My Vitamin D levels are sufficient, and I agree to take Calcium and Vitamin D supplements during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to up to end of study (approximately 85 days in part a, approximately 169 days in part b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Area under the concentration time curve (AUC) of AGA2115

Maximum observed concentration (Cmax) of AGA2115

Time to maximum observed concentration (Tmax) of AGA2115

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AGA2115Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo.

0 / 3Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Angitia Incorporated LimitedLead Sponsor

Angitia Medical DirectorStudy DirectorAngitia Incorporated Limited

3 Previous Clinical Trials

550 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available spots for volunteers in this clinical trial?

"According to details on clinicaltrials.gov, this trial is currently looking for participants and was first published on October 3rd 2023 with its last update occurring 8 days later."

Answered by AI

Has the FDA accepted AGA2115 for clinical use?

"Our team at Power deemed AGA2115's safety to be a 1, as this is merely a Phase 1 trial and henceforth there exists limited supportive data for efficacy and security."

Answered by AI

Is the age range for this medical study restricted to individuals aged 40 or younger?

"The parameters for this medical experiment require that participants are within the age range of 12 and 65. For applicants who fall outside those ages, there is a seperate set of trials: 10 for individuals below 18 years old and 3 specifically designed for elderly patients."

Answered by AI

To what extent is the capacity of this experiment limited by participant registration?

"Affirmative. According to the details available on clinicaltrials.gov, this medical experiment is presently recruiting participants and has been since October 3rd 2023. The trial requires 96 people at 1 particular site for its completion."

Answered by AI