Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy
NCT ID: NCT01847573
Last Updated: 2020-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
17 participants
INTERVENTIONAL
2013-05-31
2016-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open Label Extension Study of HT-100 in Patients With DMD
NCT01978366
A Phase 1b Study of SMT C1100 in Subjects With Duchenne Muscular Dystrophy (DMD)
NCT02056808
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
NCT04033159
HT-100 Long-term Study in DMD Patients Who Completed HALO-DMD-02
NCT02525302
A Study of ATL1102 or Placebo in Participants With Non-ambulatory Duchenne Muscular Dystrophy
NCT05938023
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: HT-100 tablet, Dose 1
* Single dose administration: Dose 1
* Multiple dose administration: Dose 1
HT-100
May be administered in either fed or fasted state
Cohort 2: HT-100 tablet, Dose 2
* Single dose administration: Dose 2
* Multiple dose administration: Dose 2
HT-100
May be administered in either fed or fasted state
Cohort 3: HT-100 tablet, Dose 3
* Single dose administration: Dose 3
* Multiple dose administration: Dose 3
HT-100
May be administered in either fed or fasted state
Cohort 4a: HT-100 tablet, Dose 4
* Single dose administration: Dose 4
* Multiple dose administration: Dose 4
HT-100
May be administered in either fed or fasted state
Cohort 4b: HT-100 tablet, Dose 5
\* Multiple dose administration: Dose 5
HT-100
May be administered in either fed or fasted state
Cohort 5: HT-100 tablet, Dose 6
\* Multiple dose administration: Dose 5
HT-100
May be administered in either fed or fasted state
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HT-100
May be administered in either fed or fasted state
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of DMD with confirmation of minimal to no dystrophin
* Corticosteroid naive or on therapy for at least 12 months (stable dose and regimen)
Exclusion Criteria
* Inability to undergo magnetic resonance imaging (MRI)
* Significantly compromised cardio-respiratory function
* Prior treatment with another investigational product in past 6 months
6 Years
20 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Processa Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Diana M Escolar, MD
Role: STUDY_DIRECTOR
Akashi Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Davis Medical Center
Sacramento, California, United States
Kennedy Krieger Institute, Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor company website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HALO
Identifier Type: OTHER
Identifier Source: secondary_id
HALO-DMD-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.