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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03559166




Registration number
NCT03559166
Ethics application status
Date submitted
24/04/2018
Date registered
5/06/2018
Date last updated
14/01/2019

Titles & IDs
Public title
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
Scientific 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
Secondary ID [1] 0 0
B-2660-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLD-2660

Placebo Comparator: cohort 1 a-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 (optional cohort) - Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).

Placebo Comparator: cohort 2 a-1st MAD cohort - Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers

Placebo Comparator: cohort 2b- 2nd MAD escalation - Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

Placebo Comparator: cohort 2c-3rd MAD escalation - Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

Placebo Comparator: cohort 3a - Therapeutic oral dose (as determined by SAD and MAD data) of BLD-2660 or placebo capsule(s) administered to participants with lung fibrosis

Placebo Comparator: cohort 3 b - Therapeutic oral dose (as determined by SAD and MAD data) of BLD-2660 or placebo capsule(s) administered to participants with liver fibrosis


Treatment: Drugs: BLD-2660
Randomized to active product or placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs) - AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
2 weeks
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
2 weeks
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
2 weeks
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
2 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Blade Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
First in Human single ascending dose followed by multiple ascending doses in healthy
volunteers followed by multi dose in participants with lung or liver fibrosis.
Trial website
https://clinicaltrials.gov/show/NCT03559166
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Snyder, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nancy Havrilla, MS, RN
Address 0 0
Country 0 0
Phone 0 0
530.417.0496
Fax 0 0
Email 0 0
nhavrilla@blademed.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable