RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
This trial has been completed.
|Condition||idiopathic pulmonary fibrosis|
|Treatments||inhaled td139, placebo|
|Phase||phase 1/phase 2|
|Sponsor||Galecto Biotech AB|
|Start date||September 2014|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT02257177, GB-HV-01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Exeter, United Kingdom||Royal Devon & Exeter Foundation NHS Trust||completed|
|Edinburgh, United Kingdom||Edinburgh University Hospital||completed|
|Newcastle, United Kingdom||The Newcastle Upon Tyne Hospitals NHS Foundation Trust||completed|
|Merthyr Tydfil, United Kingdom||Simbec Research Limited||completed|
|London, United Kingdom||Royal Brompton Hospital||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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
Male or female participants from 45 years up to 85 years old.
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.
|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)|
|Principal investigator||Toby Maher, MD|
|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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