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A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease

NCT03888716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-10-20

No results posted yet for this study

Summary

This will be a double blind, randomised, placebo controlled, single and multiple oral dose study conducted in 3 parts: Part A, Part B and Part C. Part A and Part B include healthy volunteers only and will be completed before Part C including patients with primary mitochondrial disease will be initiated. The starting dose in the first cohort of Part A will be 25 mg. The dose level in the additional cohorts will be decided following review of data of the previous cohorts.

Conditions

  • Mitochondrial Diseases
  • Mitochondrial Respiratory Chain Deficiencies
  • MELAS Syndrome
  • Mitochondrial Myopathies

Interventions

DRUG

KL1333

25 and 100 mg KL1333 encapsulated tablets

DRUG

Placebo Oral Tablet

25 and 100 mg placebo encapsulated tablets

Sponsors & Collaborators

  • Abliva AB

    lead INDUSTRY

Principal Investigators

  • Matilda Hugerth, MSc · Abliva AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2021-03-16
Completion
2021-03-16

Countries

  • United Kingdom

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 NCT03888716 on ClinicalTrials.gov