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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04001998




Registration number
NCT04001998
Ethics application status
Date submitted
26/06/2019
Date registered
28/06/2019
Date last updated
30/10/2020

Titles & IDs
Public title
Healthy Volunteer Study Comparing Tablet and Capsule Formulations
Scientific title
A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation
Secondary ID [1] 0 0
B-2660-102
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

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

Experimental: Tablet vs Capsule Formulation - Single oral dose of BLD-2660 capsule or tablet formulation

Experimental: Dose Proportionality - Single oral dose of BLD-2660 tablet formulation


Treatment: Drugs: BLD-2660
Randomized to active product
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Timepoint [1] 0 0
Up to 40 days
Primary outcome [2] 0 0
AUC from time 0 to infinity (AUC0-inf)
Timepoint [2] 0 0
Up to 40 days
Primary outcome [3] 0 0
Maximum observed drug concentration (Cmax)
Timepoint [3] 0 0
Up to 40 days
Primary outcome [4] 0 0
Time of the maximum drug concentration (Tmax)
Timepoint [4] 0 0
Up to 40 days
Primary outcome [5] 0 0
Apparent terminal half-life (t½)
Timepoint [5] 0 0
Up to 40 days
Primary outcome [6] 0 0
Apparent terminal elimination rate constant (Kel)
Timepoint [6] 0 0
Up to 40 days
Secondary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to 40 days

Eligibility
Key inclusion criteria
- Able to provide written informed consent

- Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing

- Normal BMI (18 to = 35 kg/m2)

- 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 90 days following completion of dosing

- Females of childbearing potential must have a negative serum pregnancy test at
Screening and a negative urine or serum pregnancy test on Day -1

- Be in general good health

- Clinical laboratory values within normal range
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Recent wound, or presence of an ongoing non-healing skin wound

- 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 30 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 2 years, with the exception of
completely excised basal cell carcinoma or low grade cervical intraepithelial
neoplasia

- Antibiotic treatment within 3 months

- Chronic medical condition

- Any acute illness within 30 days prior

Other protocol defined inclusion/exclusion criteria could apply.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2021
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

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

Ethics approval
Ethics application status

Summary
Brief summary
Single center, randomized, open label, two-part crossover study designed to evaluate the PK,
food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy
volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04001998
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charlotte Lemech, MD
Address 0 0
Scientia Clinical Research
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04001998