First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
- Registration Number
- NCT03559166
- Lead Sponsor
- Blade Therapeutics
- Brief Summary
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- Able to provide written informed consent
- Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
- Have a negative urine drug screen/alcohol breath test on admission to clinic
- Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 30 days following completion of dosing
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1
- Normal BMI except liver fibrosis participants (BMI 18 to ≤35 kg/m2)
- Be in general good health
- Clinical laboratory values within normal range
- Lung fibrosis participants-a diagnosis of lung fibrosis,
- Liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration
Exclusion Criteria
- 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
- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
- Blood donation or significant blood loss within 60 days prior to the first study drug administration
- Plasma donation within 7 days prior to the first study drug administration
- Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
- Females who are pregnant or lactating
- Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
- Failure to satisfy the PI of fitness to participate for any other reason
- Active infection or history of recurrent infections
- Active malignancy and history of malignancy in the past 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
- Chronic obstructive pulmonary disease
- Antibiotic treatment within 3 months
- Chronic medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description cohort 1a - starting dose BLD-2660 Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers cohort 1b- first SAD escalation BLD-2660 Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation) cohort 2b-2nd MAD escalation BLD-2660 Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. cohort 2d-4th MAD escalation BLD-2660 Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. cohort 1e-4th SAD escalation BLD-2660 Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe). cohort 1c-2nd SAD escalation BLD-2660 Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (2nd dose escalation) in fasting state, followed by washout period and then single oral dose of BLD-2660 or placebo administered to healthy volunteers in fed state. cohort 1d-3rd SAD escalation BLD-2660 Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation) cohort 2a-1st MAD cohort BLD-2660 Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers cohort 2c-3rd MAD escalation BLD-2660 Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. cohort 2e-5th MAD escalation BLD-2660 Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. cohort 2F-6th MAD escalation BLD-2660 Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) 2 weeks AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Any observed changes in clinical safety laboratory results 2 weeks Assessed by reviewing any observed changes in CBC, serum chemistry or urinalysis from baseline by dose. Results in subjects dosed with BLD-2660 treatment will be compared to those dosed with placebo.
Any observed changes in physical examinations 2 weeks Assessed by reviewing any observed changes in physical examinations from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
Any observed changes in vital signs 2 weeks Assessed by reviewing any observed changes in vital signs from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
Any observed changes in ECG 2 weeks Assessed by reviewing any observed changes in ECG from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Melbourne, Victoria, Australia