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Clinical Trial Summary

1. Part 1 Randimization, Double blinded, Placebo controlled, Dose escalation(10mg, 20mg, 40mg) of MIT-001 SC or IV single administration to evaluate safety, tolerability and PK in healthy adult. 2. Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple administration for 7days (20mg & 40mg) to evaluate safety, tolerability and PK in healthy adult.


Clinical Trial Description

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple dose, dose escalation clinical trial in 40 healthy subjects. This study consists of part 1(single dose for group 1, 2, 3) and part 2(multiple dose for 7 days to group 1 and 2). Subjects will be assigned in 6:2 allocation to receive active or placebo treatments. The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic properties of MIT-001 after single and multiple subcutaneous administration in healthy adults and to compare IV administration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05389696
Study type Interventional
Source MitoImmune Therapeutics
Contact
Status Completed
Phase Phase 1
Start date May 13, 2022
Completion date April 28, 2023

See also
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