This trial is active, not recruiting.

Condition idiopathic pulmonary fibrosis
Treatments inhaled td139, placebo
Phase phase 1/phase 2
Sponsor Galecto Biotech AB
Start date September 2014
End date September 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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
placebo inhaled placebo
DPI placebo
(Active Comparator)
inhaled TD139 single dose escalation
inhaled td139 TD139
DPI Galectin-3 inhibitor
(Placebo Comparator)
placebo inhaled placebo
DPI placebo
(Active Comparator)
Inhaled TD139 od 2 weeks
inhaled td139 TD139
DPI Galectin-3 inhibitor

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Patients will be followed for 2 weeks

Secondary Outcomes

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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Galecto Biotech AB.