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Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia

NCT05285540 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-03-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This single ascending dose study is randomized, double-blind, placebo-controlled.

Conditions

  • Friedreich Ataxia

Interventions

DRUG

DT-216

DT-216 will be administered by intravenous (IV) injection

DRUG

DT-216 matching Placebo

Placebo will be administered by intravenous (IV) injection

Sponsors & Collaborators

  • Design Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2022-12-19
Completion
2022-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285540 on ClinicalTrials.gov