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

Tracking Information

• First Submitted Date: September 29, 2014
• First Posted Date: October 6, 2014
• Last Update Posted Date: January 5, 2017
• Study Start Date: September 2014
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 2, 2014): Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for 2 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 2, 2014)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
• 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)
• 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.

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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: Inhaled TD139
  DPI Galectin-3 inhibitor
  Other Name: TD139
• Drug: Placebo
  DPI placebo
  Other Name: inhaled placebo

Study Arms

• Placebo Comparator: HV placebo arm
  placebo
  Intervention: Drug: Placebo
• Active Comparator: HV treatment arm
  inhaled TD139 single dose escalation
  Intervention: Drug: Inhaled TD139
• Placebo Comparator: IPF patient placebo arm
  placebo
  Intervention: Drug: Placebo
• Active Comparator: IPF patient treatment arm
  Inhaled TD139 od 2 weeks
  Intervention: Drug: Inhaled TD139

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 2, 2014): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02257177
• Other Study ID Numbers: GB-HV-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Interim data from the patient trial will be presented at ICLAF, Dublin 2016

• Responsible Party: Galecto Biotech AB
• Study Sponsor: Galecto Biotech AB
• Collaborators: Not Provided

Investigators

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

• PRS Account: Galecto Biotech AB
• Verification Date: January 2017