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