Title
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
A Phase Ia/Ib, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BLD-2660 in Healthy Volunteers and Patients With Lung Fibrosis or Liver Fibrosis
Phase
Phase 1Lead Sponsor
Blade TherapeuticsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
FibrosisIntervention/Treatment
bld-2660 ...Study Participants
88First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)
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.
Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
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
