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

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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

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Inhaled TD139 Drug: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Placebo Comparator: HV placebo arm
placebo
Drug: Placebo
DPI placebo
Other Name: inhaled placebo

Active Comparator: HV treatment arm
inhaled TD139 single dose escalation
Drug: Inhaled TD139
DPI Galectin-3 inhibitor
Other Name: TD139

Placebo Comparator: IPF patient placebo arm
placebo
Drug: Placebo
DPI placebo
Other Name: inhaled placebo

Active Comparator: IPF patient treatment arm
Inhaled TD139 od 2 weeks
Drug: Inhaled TD139
DPI Galectin-3 inhibitor
Other Name: TD139




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for 2 weeks ]

Secondary Outcome Measures :
  1. Serum concentration of TD139 following inhalation of TD139 [ Time Frame: PK will be measured at intervals during 2 weeks treatment ]
  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257177


Locations
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United Kingdom
Royal Devon & Exeter Foundation NHS Trust
Exeter, Devon, United Kingdom, EX2 5DW
Edinburgh University Hospital
Edinburgh, Scotland, United Kingdom, EH16 4SA
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, Tyne and Wear, United Kingdom, NE3 3HD
Simbec Research Limited
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Galecto Biotech AB
Investigators
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Principal Investigator: Toby Maher, MD Royal Brompton & Harefield NHS Foundation Trust

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Responsible Party: Galecto Biotech AB
ClinicalTrials.gov Identifier: NCT02257177     History of Changes
Other Study ID Numbers: GB-HV-01
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Interim data from the patient trial will be presented at ICLAF, Dublin 2016

Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial