Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03559166
Ethics application status
Date submitted
24/04/2018
Date registered
18/06/2018
Date last updated
19/03/2020

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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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

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

Experimental: 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 - 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 2d-4th MAD escalation - Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

Placebo comparator: cohort 2e-5th MAD escalation - Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

Placebo comparator: cohort 2F-6th MAD escalation - Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.


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)
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
Any observed changes in clinical safety laboratory results
Timepoint [2] 0 0
2 weeks
Primary outcome [3] 0 0
Any observed changes in physical examinations
Timepoint [3] 0 0
2 weeks
Primary outcome [4] 0 0
Any observed changes in vital signs
Timepoint [4] 0 0
2 weeks
Primary outcome [5] 0 0
Any observed changes in ECG
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/10/2019
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03559166