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

Study Purpose

First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03559166
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Blade Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ben Snyder, MD
Principal Investigator Affiliation	Nucleus Network
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibrosis

Arms & Interventions

Arms

Placebo Comparator: cohort 1a - starting dose

Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers

Placebo Comparator: cohort 1b- first SAD escalation

Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)

Placebo Comparator: cohort 1c-2nd SAD 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.

Placebo Comparator: cohort 1d-3rd SAD escalation

Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)

Placebo Comparator: cohort 1e-4th SAD escalation

Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).

Placebo Comparator: cohort 2a-1st MAD cohort

Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers

Placebo Comparator: cohort 2b-2nd MAD escalation