Study of DTRI-031 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Pharmacokinetics; Pharmacodynamics
• Intervention / Treatment: Drug: DTRI-031; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: DTRI-031; Investigational drug
Placebo Comparator: Placebo Comparator: Single Dose Placebo; Drug: Placebo Single doses of placebo delivered via intravenous injection, matched to DTRI-031 cohorts	Drug: Placebo; Matching placebo to DTRI-031

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by adverse events (AEs)	Incidence of treatment-emergent AEs	From dosing (DTRI-031 or placebo) to final visit (Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Plasma von Willebrand Factor (vWF) levels	Level of vWF following single administration of drug	From dosing to 24 hours after dosing
Platelet Function	Whole blood platelet function closure times	From dosing to 24 hours after dosing

Collaborators and Investigators

• Sponsor: Basking Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): April 19, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BB-CLIN-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No