Overview

First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis

Status:
Completed
Trial end date:
2019-10-04
Target enrollment:
0
Participant gender:
All
Summary
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Blade Therapeutics
Criteria
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