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RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02257177
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Galecto Biotech AB

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 6, 2014
Last Update Posted Date January 5, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Serum concentration of TD139 following inhalation of TD139 [ Time Frame: PK will be measured at intervals during 2 weeks treatment ]
  • Concentration of TD139 in alveolar macrophages after inhalation of TD139 [ Time Frame: Concentration will be measured after 2 weeks treatment with TD139 ]
    Alveolar macrophages are collected from Bronchoalveolar lavage in IPF patients before and after 2 weeks treatment with TD139
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
Official Title  ICMJE A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.
Detailed Description

Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an ascending dose fashion.

A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on pre-clinical efficacy and safety data.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: Inhaled TD139
    DPI Galectin-3 inhibitor
    Other Name: TD139
  • Drug: Placebo
    DPI placebo
    Other Name: inhaled placebo
Study Arms  ICMJE
  • Placebo Comparator: HV placebo arm
    placebo
    Intervention: Drug: Placebo
  • Active Comparator: HV treatment arm
    inhaled TD139 single dose escalation
    Intervention: Drug: Inhaled TD139
  • Placebo Comparator: IPF patient placebo arm
    placebo
    Intervention: Drug: Placebo
  • Active Comparator: IPF patient treatment arm
    Inhaled TD139 od 2 weeks
    Intervention: Drug: Inhaled TD139
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subject or female subject of non child-bearing potential with IPF.
  • Subjects aged between 45 and 85 years of age.
  • Subjects with an FVC (Forced Vital Capacity) ≥ 45% predicted and an FEV1 (Forced Expiratory Flow) /FVC ratio ≥ 0.7.
  • Subjects with oxygen saturation >90% by pulse oximetry while breathing ambient air at rest.
  • Subjects with a diffusing capacity (DLCO - transfer fact of the lung for carbon monoxide) >25%.
  • Subjects with a diagnosis consistent with IPF prior to screening based on ATS/ERS/JRS/ALAT (American, European, Japanese and Latin American Respiratory Societies) consensus criteria.
  • Subjects who are able to undergo bronchoalveolar lavage (BAL).
  • Subjects able to provide written informed consent to participate in the study.
  • Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
  • Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days of the first dose.
  • Subjects with a negative urinary drugs of abuse screen, determined within 28 days of the first dose.

Exclusion Criteria:

  • Any condition that makes the patient at unacceptable risk for bronchoscopy.
  • Active cigarette smoking.
  • Presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.
  • HRCT (high resolution CT scan) pattern showing emphysema more than the extent of fibrosis of the lung area conducted within 12 months of Day 1.
  • Evidence of renal, hepatic, central nervous system, or metabolic dysfunction.
  • Evidence of poorly controlled diabetes mellitus (defined as a HbA1c of > 59 mmol/mol [7.5%]).
  • Use of systemic immunosuppressants within 30 days of dosing.
  • Subjects currently receiving oral corticosteroids, cytotoxic drugs (e.g. chlorambucil, azathioprine, cyclophosphamide, methotrexate), antifibrotic drugs (e.g. pirfenidone), vasodilator therapies for pulmonary hypertension (e.g bosentan), unapproved (e.g. Interferon-γ, penicillamine, cyclosporine, mycophenolate) and/or investigational therapies for IPF or administration of such therapies within 4 weeks of initial screening.
  • History of malignancy, including carcinoma during the preceding five years.
  • History of, or current asthma.
  • Participation in a clinical study of an unlicensed drug in the previous 4 months, or a marketed drug study within the previous 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02257177
Other Study ID Numbers  ICMJE GB-HV-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Interim data from the patient trial will be presented at ICLAF, Dublin 2016
Responsible Party Galecto Biotech AB
Study Sponsor  ICMJE Galecto Biotech AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Toby Maher, MD Royal Brompton & Harefield NHS Foundation Trust
PRS Account Galecto Biotech AB
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP