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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05005520
Other study ID # BB-CLIN-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 20, 2021
Est. completion date April 19, 2022

Study information

Verified date July 2022
Source Basking Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031


Description:

Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort. Subjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28. A Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 19, 2022
Est. primary completion date April 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
DTRI-031
Investigational drug
Placebo
Matching placebo to DTRI-031

Locations

Country Name City State
Australia Nucleus Network Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Basking Biosciences, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as assessed by adverse events (AEs) Incidence of treatment-emergent AEs From dosing (DTRI-031 or placebo) to final visit (Day 28)
Secondary Pharmacokinetics as measured by DTRI-031 plasma levels Plasma concentration of DTRI-031 (after single dose of drug) From dosing to 24 hours after dosing
Secondary Plasma von Willebrand Factor (vWF) levels Level of vWF following single administration of drug From dosing to 24 hours after dosing
Secondary Platelet Function Whole blood platelet function closure times From dosing to 24 hours after dosing
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