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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT02257177
• Date of registration: 29/09/2014
• Prospective Registration: No
• Primary sponsor: Galecto Biotech AB
• Public title: RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
• Scientific 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)
• Date of first enrolment: September 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02257177
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Toby Maher, MD
• Affiliation: Royal Brompton & Harefield NHS Foundation Trust

Key inclusion & exclusion criteria

Part 1 Inclusion Criteria

- 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 continued to meet all screening inclusion criteria.

- Subject with a negative urinary drugs of abuse screen (including alcohol) prior to
dosing.

Exclusion Criteria

- 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:

- Development of any exclusion criteria since screening.

- 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).

Part 2 Inclusion Criteria

- Male patient or female patient of non childbearing potential with IPF.

- Male patient willing to use a condom, if applicable (unless anatomically sterile or
where abstaining from sexual intercourse was in line with the preferred and usual
lifestyle of the patient) from the first dose until at least 3 months after receiving
the last dose of IMP.

- Aged between 45 and 85 years of age.

- With a forced vital capacity (FVC) = 45% predicted and forced expiratory volume in 1
second (FEV1)/FVC ratio = 0.7.

- Oxygen saturation > 90% by pulse oximetry while breathing ambient air at rest.

- Diffusing capacity of lungs for carbon monoxide (DLCO) > 25%.

- Had adequate organ function and a clinical diagnosis consistent with IPF prior to
screening (based on the American Thoracic Society, the European Respiratory Society,
the Japanese Respiratory Society and the Latin American Thoracic Association
(ATS/ERS/JRS/ALAT) consensus criteria. The diagnosis would ordinarily have been
confirmed at a multidisciplinary team meeting where the high resolution computed
tomography (HRCT) findings in particular would have been discussed with a radiologist
with respiratory expertise.

- Able to undergo BAL.

- Provided written informed consent to participate in the study.

- Available to complete the study (including all follow up visits).

- Negative urinary drugs of abuse screen, determined within 28 days of the first dose of
IMP (N.B. a positive alcohol result could have been repeated at the discretion of the
Investigator).

- Negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B)
and hepatitis C virus antibody (Hep C) results.

- No clinically significant abnormalities in 12 lead ECG determined within 28 days of
the first dose of IMP.

Confirmed at Baseline / Prior to First Dose:

- Patient continued to meet all screening inclusion criteria. Exclusion Criteria

- Any condition that made the patient at unacceptable risk for bronchoscopy.

- Active cigarette smoking (defined as smoking more than 3 cigarettes daily within the
last 6 months).

- Presence of a significant co morbidity felt to limit life expectancy to less than 12
months.

- HRCT pattern showing emphysema more than the extent of fibrosis of the lung area
conducted within 12 months of first dose.

- Evidence of renal, hepatic, central nervous system, or metabolic dysfunction.

- Evidence of poorly controlled diabetes mellitus (defined as a


Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Inhaled TD139

Drug: Placebo

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: 0 - 30 days]

Secondary ID(s)

GB-HV-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/04/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02257177