Healthy Volunteers, Pharmacodynamics, Pharmacokinetics
Conditions
Brief 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
Detailed 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.
Interventions
DRUGDTRI-031
Investigational drug
DRUGPlacebo
Matching placebo to DTRI-031
Sponsors
Basking Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded, placebo-controlled
Intervention model description
Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of a single dose of investigational drug or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by adverse events (AEs) | From dosing (DTRI-031 or placebo) to final visit (Day 28) | Incidence of treatment-emergent AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics as measured by DTRI-031 plasma levels | From dosing to 24 hours after dosing | Plasma concentration of DTRI-031 (after single dose of drug) |
| Plasma von Willebrand Factor (vWF) levels | From dosing to 24 hours after dosing | Level of vWF following single administration of drug |
| Platelet Function | From dosing to 24 hours after dosing | Whole blood platelet function closure times |
Countries
Australia
Outcome results
None listed