Back to resultsFirst in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
Primary Purpose
Fibrosis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BLD-2660
Sponsored by
About this trial
This is an interventional treatment trial for Fibrosis
Eligibility 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
Sites / Locations
- Nucleus Network
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
cohort 1a - starting dose
cohort 1b- first SAD escalation
cohort 1c-2nd SAD escalation
cohort 1d-3rd SAD escalation
cohort 1e-4th SAD escalation
cohort 2a-1st MAD cohort
cohort 2b-2nd MAD escalation
cohort 2c-3rd MAD escalation
cohort 2d-4th MAD escalation
cohort 2e-5th MAD escalation
cohort 2F-6th MAD escalation
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Any observed changes in clinical safety laboratory results
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03559166
Brief Title
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
October 4, 2019 (Actual)
Study Completion Date
October 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blade Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized, double-blind, placebo controlled
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cohort 1a - starting dose
Arm Type
Experimental
Arm Description
Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers
Arm Title
cohort 1b- first SAD escalation
Arm Type
Placebo Comparator
Arm Description
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)
Arm Title
cohort 1c-2nd SAD escalation
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
cohort 1d-3rd SAD escalation
Arm Type
Placebo Comparator
Arm Description
Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)
Arm Title
cohort 1e-4th SAD escalation
Arm Type
Placebo Comparator
Arm Description
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).
Arm Title
cohort 2a-1st MAD cohort
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers
Arm Title
cohort 2b-2nd MAD escalation
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Arm Title
cohort 2c-3rd MAD escalation
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Arm Title
cohort 2d-4th MAD escalation
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Arm Title
cohort 2e-5th MAD escalation
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Arm Title
cohort 2F-6th MAD escalation
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
Intervention Type
Drug
Intervention Name(s)
BLD-2660
Other Intervention Name(s)
Placebo
Intervention Description
Randomized to active product or placebo
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Time Frame
2 weeks
Title
Any observed changes in clinical safety laboratory results
Description
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.
Time Frame
2 weeks
Title
Any observed changes in physical examinations
Description
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.
Time Frame
2 weeks
Title
Any observed changes in vital signs
Description
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.
Time Frame
2 weeks
Title
Any observed changes in ECG
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Snyder, MD
Organizational Affiliation
Nucleus Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nucleus Network
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
We'll reach out to this number within 24 hrs