Clinical trial NCT05005520: Study of DTRI-031 in Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Basking Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety as assessed by adverse events (AEs)
timeFrame: From dosing (DTRI-031 or placebo) to final visit (Day 28)
Secondary outcomes:
measure: Pharmacokinetics as measured by DTRI-031 plasma levels
timeFrame: From dosing to 24 hours after dosing
measure: Plasma von Willebrand Factor (vWF) levels
timeFrame: From dosing to 24 hours after dosing
measure: Platelet Function
timeFrame: From dosing to 24 hours after dosing
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References: