clinical trial · NCT05579691
A Double-Blind, Placebo-Controlled, Dose Exploration Study of CTI-1601 in Adult Subjects With Friedreich's Ataxia
Friedreich AtaxiaCTI-1601Placebo
brief summary
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration of CTI-1601 over 28 days in subjects with Friedreich's ataxia (FRDA).
started
Sep 21, 2022
primary completion
Dec 4, 2023
completion
Dec 4, 2023
last updated
Nov 29, 2024
detailed description
This is a double-blind, placebo-controlled, study evaluating two doses (25 mg and 50 mg) of CTI-1601.
This study will consist of at least 2 cohorts with 12 to 15 subjects participating in each cohort. Subjects will be dosed once daily (QD) for 14 days followed by dosing every other day (QOD) through Day 28.
official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Exploration Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 in Adult Subjects With Friedreich's Ataxia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol