NCT05389696

Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC Administration in Healthy Subjects

Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of MIT-001 After Subcutaneous and Intravenous Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: MitoImmune Therapeutics · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Heathly Subjects

Interventions

Type	Name	Description
DRUG	Single subcutaneous administration and Blood collection	Single subcutaneous administration and Blood collection
DRUG	Single subcutaneous administration and then IV injection.	Single subcutaneous administration and then single intravenous administration after 2 weeks. In addition Blood collection is conducted as scheduled.
DRUG	MIT-001 20mg and 40mg_Multiple administration	Multiple subcutaneous administration for 7 days and then blood collection

Timeline

• Start date: 2022-05-13
• Primary completion: 2023-02-13
• Completion: 2023-04-28
• First posted: 2022-05-25
• Last updated: 2023-08-24

Locations

1 site across 1 country: South Korea