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CompletedPhase 1

The Safety and Tolerability of CLZ-2002 in Patients With Charcot-Marie Tooth Disease.

Key facts

Who runs it
Cellatoz Therapeutics, Inc
Where
South Korea1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 1
People taking part
9 people enrolled
Started
19 Jun 2023
Ended
9 Aug 2024
Type of study
Interventional
Treatments tested
  • CLZ-2002
Record updated
17 February 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Subjects aged 18 years or older
  • Subjects with a proven diagnosis of Charcot-Marie-Tooth disease type 1 at the time of screening visit
  • Subjects who have muscle weakness in at least foot dorsiflexion (clinical assessment) at the time of screening visit
  • Subjects with a CMT neuropathy score (CMTNS-v2) of 2 or more and 30 or fewer points at the time of screening visit
  • Subjects who can understand and are willing to sign a written informed consent document are willing to comply with all study procedures and schedule visits

Who cannot take part

  • Subjects who have undergone upper and lower limb bone surgery within six months before screening visit
  • Subjects who have concerns about muscle strength measurements due to the previous surgery
  • Subjects who have a history of unstable cardiovascular disease defined by the presence of myocardial infarction (STEMI or NSTEMI) within 6 months before the screening or the presence of unstable angina pectoris (in the case of increased frequency of symptoms, increased severity, or signs of prolonged symptoms at moderate activity or rest)
  • Subjects who have a history of a transient ischemic attack (TIA) or stroke within 6 months before screening visit
  • Subjects who have received systemic steroids (inhaled steroids are allowed), immunotherapy, or cytotoxic therapy within 14 days before screening, or who are expected to receive such treatment during the study period
  • Subjects who have participated in other clinical trials within 30 days before screening visit
  • Pregnant and lactating women or women of childbearing potential and men who plan a pregnancy or are unwilling to use adequate birth control methods\& until 30 days after the end of drug administration
  • Subjects who have any other neuromuscular diseases
  • Subjects who have severe active infection including severe/purulent cellulitis at the injection sites at screening visit
  • Subjects who have a history of hospitalization due to hypersensitivity to antihistamines or allergy or hypersensitivity to certain substances such as food or drugs
  • Subjects who have a positive HIV antibody test, hepatitis B antigen, or hepatitis C antibody test result
  • Subjects who have a history of malignant tumors within 5 years before screening visit

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

A Phase 1, Open-Label, Prospective, Dose-finding Clinical Trial for Evaluation of Safety and Tolerability of Intramuscular Injections of CLZ-2002 for the Treatment of Subjects with Charcot-Marie-Tooth type 1(CMT 1)

The group in the trial

  • CLZ-2002Treatment being tested

    CLZ-2002 injection is intramuscular in lower limbs on Day 1.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1, Open-Label, Prospective, Dose-finding Clinical Trial for Evaluation of Safety and Tolerability of Intramuscular Injections of CLZ-2002 for the Treatment of Subjects With Charcot-Marie-Tooth Type 1(CMT 1)
Record updated
17 February 2025