| Eligibility |
Inclusion Criteria:
To be eligible for inclusion into this study, each subject must fulfill the following
inclusion criteria within 20 days prior to Randomization on Day 1:
Age and Gender
1. Male subjects 45 years of age and over, or female subjects 50 years of age and over,
at the time of signing the informed consent.
Diagnosis and disease characteristics
2. Subjects with diagnosis of IPF as defined by the American Thoracic Society/European
Respiratory Society International Multidisciplinary Consensus Classification of
Idiopathic Interstitial Pneumonia.
3. Forced vital capacity (FVC) >45% predicted and diffusing capacity of the lung for
carbon monoxide (DLCO) >30% predicted.
4. Alanine aminotransferase (ALT) within normal limit (WNL).
5. Aspartate aminotransferase (AST) and alkaline phosphatase (ALP) =1.2× upper limit of
normal (ULN).
6. Total bilirubin =ULN (isolated bilirubinemia =2× ULN is acceptable if direct bilirubin
to total bilirubin ratio <0.35).
7. Body mass index (BMI) up to 35 kg/m2 inclusive. Reproductive Considerations
Contraception use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
8. All subjects (male or female) who are of childbearing potential must agree to use
highly effective contraception during the study.
9. Male subjects and female partners of male subjects must continue to use highly
effective contraception for 90 days after the last dose of study drug (see Medicines
and Healthcare products Regulatory Agency, 2019 for further guidance regarding highly
effective contraception). Male subjects must agree not to donate sperm for 90 days
after last dose of study drug.
10. Female subjects and male partners of female subjects must continue to use highly
effective contraception for 60 days after the last dose of study drug. Female subjects
should not donate oocytes during this time.
11. Female subjects of childbearing potential must have a negative serum pregnancy test at
Screening and a negative urine pregnancy test on Day (-1). Women of childbearing
potential (WOCBP) must agree to undergo pregnancy testing at regular intervals
throughout the study.
12. Female subjects not of childbearing potential as defined by being postmenopausal (with
cessation of regular menstrual periods for at least 1 year), confirmed by follicle
stimulating hormone (FSH) level, or be surgically sterile.
Informed Consent
13. Subjects must provide signed informed consent prior to study entry and have the
ability and willingness to attend and comply with the necessary visits at the study
site.
Exclusion Criteria:
To be eligible for inclusion into this study, each subject must violate none of the
following exclusion criteria within 20 days prior to Randomisation on Day 1.
Medical Conditions
1. Recent (less than 6 weeks) significant wound (in the opinion of the Investigator), or
presence of an ongoing non-healing skin wound or ulcer.
2. Presence of any underlying physical or psychological medical condition that, in the
opinion of the Investigator, would make it unlikely that the subject will complete the
study per protocol.
3. Active infection (diagnosed or suspected) or history of recurrent infections,
including but is not limited to, bronchitis, pneumonia, sinusitis, urinary tract
infection, cellulitis or chronic ongoing infectious disease within 4 weeks prior to
first dose of study drug. Note: Rescreening will be permitted after 28 days if an
infection leads to screening failure.
4. Active malignancy and/or history of malignancy in the past 5 years, except for
non-melanoma skin cancer, carcinoma in situ of the breast that has been successfully
treated, carcinoma in situ of the cervix that has been successfully treated, early
stage, untreated prostate cancer, or prostate cancer with completion of treatment >2
years prior to Screening.
5. Extensive chronic obstructive pulmonary disease (where extent of emphysema >extent of
fibrosis on computerised tomography (CT) scan or FEV1: FVC ratio <0.65).
6. Other explanation for lung fibrosis, including but not limited to radiation,
sarcoidosis, bronchiolitis obliterans organizing pneumonia, collagen vascular disease,
hypersensitivity pneumonitis, etc.
7. IPF exacerbation within last 60 days.
8. A history or current evidence of any medical condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the subjects'
participation for the full duration of the study, or is not in the best interest of
the subjects to participate, in the opinion of the Investigator.
Diagnostic Assessments
9. Positivity for Human Immunodeficiency Virus (HIV) antibody (HIV-1 and/or HIV-2) and/or
HIV-1 p24 antigen.
10. Positivity for Hepatitis C virus antibody (HCV Ab or anti-HCV) and/or Hepatitis B
surface antigen (HBsAg).
11. Absolute neutrophil count <1700/µL.
12. Significant hypoxia, requiring >2 L/min oxygen to maintain a resting oxygen saturation
>89%.
13. Poor exercise tolerance.
14. Serum troponin I level >ULN.
Prior/Concomitant Therapy
15. Use of anticoagulants that prolong Prothrombin time (PT)/International normalised
ratio (INR).
16. Use of anticoagulants within 2 days of Day (-1) (bronchoscopy). Note: The subjects who
cannot discontinue the anticoagulants within 2 days of Day (-1) bronchoscopy will be
excluded.
17. Treatment with any anti-fibrotic therapy (pirfenidone or nintedanib) within 30 days of
Screening.
18. Immunosuppressive therapy within 3 months prior to first dose of study drug (unless
for non-IPF indication).
19. Use of oral steroids >10 mg/day (or prednisolone equivalent). Note: If the subject is
on steroid dose equivalent to 10 mg/day prednisone or more, the Investigator may
decide if the tapering down to the dose of 10 mg/day prednisone is possible and safe.
20. Start of new biologic or change in biologic dose within 24 weeks prior to Day 1.
21. Cyclophosphamide within 6 months prior to the first dose of study drug (unless for
other indication).
Prior/Concurrent Clinical Study Experience
22. Administration of another investigational product, investigational device, or approved
therapy for investigational use within 30 days prior to the first study drug
administration, or five half-lives, whichever is longer.
Other Exclusions
23. Blood donation or significant blood loss within 60 days prior to the first study drug
administration.
24. Plasma donation within 7 days prior to the first study drug administration.
25. Female subjects who are pregnant or breastfeeding.
26. History or presence of alcohol or drug abuse (including recreational marijuana use)
within the 2 year prior to the first study drug administration, and unwillingness to
be totally abstinent during the dosing period.
27. Active smoker, smoking history or vaping within 4 weeks prior to the first dose of
study drug. Subjects only using Nicotine replacement therapy (NRT) may be allowed per
discretion of the Investigator.
28. Subjects with an allergy to BLD-2660 or inactive components of BLD-2660.
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