Study of DTRI-031 in Healthy Volunteers

NCT ID: NCT05005520

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-04-19

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.

Conditions

Healthy Volunteers; Pharmacokinetics; Pharmacodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

DTRI-031

Intervention Type: DRUG

Investigational drug

Placebo Comparator: Single Dose Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to DTRI-031

Interventions

DTRI-031

Investigational drug

Intervention Type: DRUG

Placebo

Matching placebo to DTRI-031

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Basking Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

BB-CLIN-101

Identifier Type: -

Identifier Source: org_study_id