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

NCT02257177 | Completed Phase 1 Results DMC

• 1 other identifier: GB-HV-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.

  0 - 30 days

Study Arms (11)

0.15 mg TD139 (Part 1)

ACTIVE COMPARATOR

4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Inhaled TD139

1.5 mg TD139 (Part 1)

ACTIVE COMPARATOR

4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Inhaled TD139

3 mg TD139 (Part 1)

ACTIVE COMPARATOR

4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Inhaled TD139

10 mg TD139 Part 1

ACTIVE COMPARATOR

4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Inhaled TD139

20 mg TD139 Part 1

ACTIVE COMPARATOR

4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Inhaled TD139

50 mg TD139 Part 1

ACTIVE COMPARATOR

4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Inhaled TD139

Placebo Part 1

PLACEBO COMPARATOR

12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Drug: Placebo

0.3 mg TD139 Part 2

ACTIVE COMPARATOR

5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.

Drug: Inhaled TD139

3 mg TD139 Part 2

ACTIVE COMPARATOR

5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.

Drug: Inhaled TD139

10 mg TD139 Part 2

ACTIVE COMPARATOR

5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.

Drug: Inhaled TD139

Placebo Part 2

PLACEBO COMPARATOR

9 Patients with IPF are administered placebo inhaled as a dry powder.

Drug: Placebo

Interventions

Inhaled TD139 DRUG

DPI Galectin-3 inhibitor

Also known as: TD139

0.15 mg TD139 (Part 1); 0.3 mg TD139 Part 2; 1.5 mg TD139 (Part 1); 10 mg TD139 Part 1; 10 mg TD139 Part 2; 20 mg TD139 Part 1; 3 mg TD139 (Part 1); 3 mg TD139 Part 2; 50 mg TD139 Part 1

Placebo DRUG

DPI placebo

Also known as: inhaled placebo

Placebo Part 1; Placebo Part 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects aged between 18 and 55 years of age.
• Male subject willing to use a condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from the Day 1 dose of study medication until 3 months afterwards.
• Subject with a body weight of at least 50 kg and a body mass index (BMI) within the range of 18 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2.
• Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 28 days of the Day 1 dose of study medication.
• Subject with a negative urinary drugs of abuse screen, determined within 28 days of the Day 1 dose of study medication, (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
• Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
• Subject with no clinically significant abnormalities in 12 lead ECG determined within 28 days of the Day 1 dose of study medication.
• Subjects were non smokers or former smokers (having ceased smoking for at least 6 months).
• Subjects with no clinically significant impairment in oxygen saturation.
• Subject satisfied a medical examiner about their fitness to participate in the study.
• Subject provided written informed consent to participate in the study.
• Subject was available to complete the study (including all follow up visits).
• Confirmed at Baseline / Prior to First Dose:
• Subject with a negative urinary drugs of abuse screen (including alcohol) prior to dosing.

You may not qualify if:

• A clinically significant illness or surgery within 8 weeks prior to the Day 1 dose of study medication.
• Significant medical history that, in the Investigator's opinion, may have adversely affected participation.
• History of allergy or significant adverse reaction to drugs similar to the investigational drug, to nicotine, or to cholinergic drugs or to any drugs with a similar chemical structure.
• History of hypersensitivity (anaphylaxis, angioedema) to any drug.
• Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to the Day 1 dose of study medication.
• Use of medications known to prolong QT/QTc interval within 14 days prior to the Day 1 dose of study medication.
• Any clinically significant findings of physical examination or laboratory findings at screening.
• A clinically significant history of drug or alcohol abuse.
• Receipt of regular/over the counter medication within 14 days of the Day 1 dose of study medication that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
• Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
• Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
• Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
• Donation of 450 mL or more blood within the previous 3 months.
• Confirmed at Baseline / Prior to First Dose:
• Receipt of any medication since screening that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).

Sponsors & Collaborators

• Galecto Biotech AB: lead

Study Sites (5)

Royal Devon & Exeter Foundation NHS Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Edinburgh University Hospital

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, Tyne and Wear, NE3 3HD, United Kingdom

Location

Simbec Research Limited

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• Hirani N, MacKinnon AC, Nicol L, Ford P, Schambye H, Pedersen A, Nilsson UJ, Leffler H, Sethi T, Tantawi S, Gravelle L, Slack RJ, Mills R, Karmakar U, Humphries D, Zetterberg F, Keeling L, Paul L, Molyneaux PL, Li F, Funston W, Forrest IA, Simpson AJ, Gibbons MA, Maher TM. Target inhibition of galectin-3 by inhaled TD139 in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2021 May 27;57(5):2002559. doi: 10.1183/13993003.02559-2020. Print 2021 May.

  PMID: 33214209 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Professor Bertil Lindmark
• Organization: Galecto

info@galecto.com

+4570705210

Study Officials

• Toby Maher, MD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 6, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 7, 2023
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (5)