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Multiple Ascending Dose Study of CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia

NCT04519567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-06-30

No results posted yet for this study

Summary

To evaluate the safety and tolerability of multiple ascending doses of CTI-1601 in participants with Friedreich's ataxia

Conditions

  • Friedreich Ataxia

Interventions

BIOLOGICAL

CTI-1601

CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia

BIOLOGICAL

Placebo

Placebo Comparator

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • Metrum Research Group, LLC

    collaborator UNKNOWN

  • Larimar Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Magdy Shenouda, M.D. · Clinilabs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2021-03-16
Completion
2021-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04519567 on ClinicalTrials.gov