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

NCT05389696 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

  • Heathly Subjects

Interventions

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

Sponsors & Collaborators

  • MitoImmune Therapeutics

    lead INDUSTRY

Principal Investigators

  • SeungHwan Lee, MD · Seoul National University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2023-02-13
Completion
2023-04-28

Countries

  • South Korea

Study Locations

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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 NCT05389696 on ClinicalTrials.gov