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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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05005520
Study type Interventional
Source Basking Biosciences, Inc.
Contact
Status Completed
Phase Phase 1
Start date October 20, 2021
Completion date April 19, 2022

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