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

• ClinicalTrials.gov Identifier: NCT02257177
• Recruitment Status: Completed
• First Posted: October 6, 2014
• Last Update Posted: January 5, 2017
• Sponsor: Galecto Biotech AB
• Information provided by (Responsible Party): Galecto Biotech AB

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Toby Maher, MD; Royal Brompton & Harefield NHS Foundation Trust

More Information

• Responsible Party: Galecto Biotech AB
• ClinicalTrials.gov Identifier: NCT02257177
• Other Study ID Numbers: GB-HV-01
• First Posted: October 6, 2014
• 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:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial