Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis
Detailed description
This is a Phase 2a, double-blind, placebo-controlled, multicentre, adaptive design study of BLD-2660 in subjects with IPF. The study will include a Screening period, a Treatment period, and a Follow-up period. Data on PK, PD, and biomarker activity will be observed.
Interventions
DRUGBLD-2660
BLD-2660 - 150 mg capsules '00' size (PO) BID
DRUGControl: Placebo
Placebo - 150 mg capsules '00' size (PO) BID
Sponsors
Blade Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed changes in ILK from baseline | 58 days | Change in RLU of BAL fluid analyzed by ILK-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular ILK from baseline. |
| Observed changes in spectrin from baseline | 58 days | Change in RLU of BAL fluid analyzed by spectrin-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular spectrin from baseline. |
| Observed changes in ezrin from baseline | 58 days | Change in RLU of BAL fluid analyzed by ezrin-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular ezrin from baseline. |
| Observed changes in S100A9 from baseline | 58 days | Change in RLU of BAL fluid analyzed by S100A9-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular S100A9 from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) | 58 days | Measured by plasma concentration |
| Incidence of Treatment-Emergent Adverse Events as assessed by PI and SMC | 58 days | AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events. |
| AUC from time 0 to infinity (AUC0-inf) | 58 days | Measured by plasma concentration |
| Maximum observed drug concentration (Cmax) | 58 days | Measured by plasma concentration |
| Time of the maximum drug concentration (Tmax) | 58 days | Measured by plasma concentration |
Countries
United Kingdom
Outcome results
None listed