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RNA Therapy

mRNA-3210 for Phenylketonuria

Phase 1 & 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 15 for dose 1 and dose 12

Awards & highlights

Study Summary

"This trial aims to evaluate how safe and well-tolerated multiple doses of mRNA-3210 are in individuals with phenylketonuria (PKU)."

Who is the study for?

This trial is for individuals with confirmed phenylketonuria (PKU) due to PAH deficiency, evidenced by genetic testing and high blood phenylalanine levels. Participants must be able to maintain their current diet and, if on neuropsychiatric medication, keep a stable dose throughout the study.Check my eligibility

What is being tested?

The study aims to evaluate the safety and tolerability of multiple doses of mRNA-3210 in people with PKU. It will involve administering this new treatment and monitoring participants for any adverse reactions or changes in their condition.See study design

What are the potential side effects?

As this is a dose-finding study for mRNA-3210, specific side effects are being investigated; however, common side effects may include injection site reactions, flu-like symptoms, headache, fatigue or possible allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 15 for dose 1 and dose 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 15 for dose 1 and dose 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 15 for dose 1 and dose 12 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 Effect Versus Time Curve (AUEC)

Area Under the Plasma Concentration-Time Curve (AUC)

Change from Baseline in Blood Phenylalanine Levels

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: mRNA-3210Experimental Treatment1 Intervention

Participants will receive single dose of mRNA-3210 by intravenous (IV) infusion every 3 weeks (Q3W), every 2 weeks (Q2W), or every 1 week (Q1W) for up to 12 doses.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,379,859 Total Patients Enrolled

Frequently Asked Questions

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

Is the study open to participants who are younger than 75 years old?

"Prospective participants must meet the age requirement of being between 18 and 70 years old to be eligible for this study. Additionally, there are separate trials available for individuals under 18 and those over 65, with a total of 11 trials in each category."

Answered by AI

Is the registration process currently ongoing for this clinical trial?

"As detailed on clinicaltrials.gov, patient recruitment is ongoing for this medical study. The trial was initially listed on 3/29/2024 and most recently revised on 4/5/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose-finding Study to Evaluate mRNA-3210 in Participants With Phenylketonuria

2024. "A Dose-finding Study to Evaluate mRNA-3210 in Participants With Phenylketonuria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06147856.

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