Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia
NCT ID: NCT05285540
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2022-03-11
2022-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia
NCT05573698
A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia
NCT06874010
A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants
NCT06772870
A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia
NCT04102501
A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients
NCT03917225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Dose: DT-216
DT-216 will be administered once
DT-216
DT-216 will be administered by intravenous (IV) injection
Single Dose: DT-216 matching placebo
Placebo will be administered once
DT-216 matching Placebo
Placebo will be administered by intravenous (IV) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DT-216
DT-216 will be administered by intravenous (IV) injection
DT-216 matching Placebo
Placebo will be administered by intravenous (IV) injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index (BMI) between 17 and 32 kg/m2
* Stage 5.5 or less on the Functional Staging for Ataxia (FSA)
Exclusion Criteria
* Has clinically significant abnormal laboratory results
* Has significant cardiac disease
* Received an investigational drug within 3 months of screening
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Design Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinilabs
Eatontown, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DTX-216-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.