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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05005520




Registration number
NCT05005520
Ethics application status
Date submitted
9/08/2021
Date registered
13/08/2021

Titles & IDs
Public title
Study of DTRI-031 in Healthy Volunteers
Scientific title
A Randomized, Double-Blind, Single-Center, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of Intravenous DTRI-031 in Healthy Volunteers
Secondary ID [1] 0 0
BB-CLIN-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Pharmacokinetics 0 0
Pharmacodynamics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DTRI-031
Treatment: Drugs - Placebo

Active comparator: Active Comparator: Single ascending dose DTRI-031 - Drug: DTRI-031 Single doses of DTRI-031 delivered via intravenous injection. Ascending dose levels will be evaluated.

Placebo comparator: Placebo Comparator: Single Dose Placebo - Drug: Placebo Single doses of placebo delivered via intravenous injection, matched to DTRI-031 cohorts


Treatment: Drugs: DTRI-031
Investigational drug

Treatment: Drugs: Placebo
Matching placebo to DTRI-031
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as assessed by adverse events (AEs)
Timepoint [1] 0 0
From dosing (DTRI-031 or placebo) to final visit (Day 28)
Secondary outcome [1] 0 0
Pharmacokinetics as measured by DTRI-031 plasma levels
Timepoint [1] 0 0
From dosing to 24 hours after dosing
Secondary outcome [2] 0 0
Plasma von Willebrand Factor (vWF) levels
Timepoint [2] 0 0
From dosing to 24 hours after dosing
Secondary outcome [3] 0 0
Platelet Function
Timepoint [3] 0 0
From dosing to 24 hours after dosing

Eligibility
Key inclusion criteria
* 18-55 years of age
* Ability to provide written consent
* Weight 50-110 kg with BMI 18.5-32 kg/m2
* Willingness to use contraceptives
* Negative COVID-19 test
* Negative results for alcohol and drugs of abuse
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant or lactating females
* Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
* Females with active menstruation on day of dosing
* Use of prescription medications known to affect platelet function
* Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
* Contraindication to anticoagulation or increased bleeding risks
* History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
* History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
* Planned surgery during the study
* Any clinical significant abnormality at screening
* Use of investigational drug in past 30 days or 5 half lives
* Concurrent enrollment in another clinical study or more than 3 clinical studies in past 12 months
* Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test

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 analysing the results/data
Intervention assignment
Parallel
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
20/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/04/2022
Sample size
Target
Accrual to date
Final
46
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
Basking Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05005520