RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: Inhaled TD139 Drug: Placebo | Phase 1 Phase 2 |
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 : | 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 |
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for 2 weeks ]
- 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

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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 |
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.

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
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 |
Principal Investigator: | Toby Maher, MD | Royal Brompton & Harefield NHS Foundation Trust |
Responsible Party: | Galecto Biotech AB |
ClinicalTrials.gov Identifier: | NCT02257177 |
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 |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |