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

Friedreich Ataxia Clinical Trial

Official title:
A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia

Clinical Trial Summary

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

Clinical Trial Description

Single Ascending Dose (SAD), Double-Blind, Placebo Controlled Study. To evaluate the safety and tolerability of single ascending doses of CTI-1601 in subjects with Friedreich's ataxia. Secondary Objectives: 1. To evaluate the pharmacokinetics (PK) of CTI-1601 following increasing single doses of subcutaneously (SC) administered CTI-1601. 2. To evaluate the pharmacodynamics (PD) of CTI-1601 following increasing single doses of SC administered CTI-1601. CTI-1601 or Placebo - Dose/Mode of Administration: Single Dose/Subcutaneous ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04176991
Study type Interventional
Source Larimar Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 11, 2019
Completion date October 31, 2020
View Details
See also
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