Study of DTRI-031 in Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005520
• Other study ID #: BB-CLIN-101
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacodynamics
• Pharmacokinetics

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