Study of DTRI-031 in Healthy Volunteers

NCT05005520 | Completed Phase 1 FDA Drug

• 1 other identifier: BB-CLIN-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by adverse events (AEs)

  Incidence of treatment-emergent AEs

  From dosing (DTRI-031 or placebo) to final visit (Day 28)

Secondary Outcomes (3)

• Pharmacokinetics as measured by DTRI-031 plasma levels

  From dosing to 24 hours after dosing

• Plasma von Willebrand Factor (vWF) levels

  From dosing to 24 hours after dosing

• Platelet Function

  From dosing to 24 hours after dosing

Study Arms (2)

Active Comparator: Single ascending dose DTRI-031

ACTIVE COMPARATOR

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

Drug: DTRI-031

Placebo Comparator: Single Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DTRI-031 DRUG

Investigational drug

Active Comparator: Single ascending dose DTRI-031

Placebo DRUG

Matching placebo to DTRI-031

Placebo Comparator: Single Dose Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basking Biosciences, Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of a single dose of investigational drug or placebo

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 13, 2021
• Study Start: October 20, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)