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A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects

NCT05325346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-11

No results posted yet for this study

Summary

The study is designed to characterize the safety and tolerability of VLX-1005 and argatroban administered intravenously, either alone or in combination; and the pharmacokinetics and pharmacodynamics and potential interaction of both agents in a population of healthy subjects.

Conditions

  • Heparin-induced Thrombocytopenia

Interventions

DRUG

VLX-1005

Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD

DRUG

Argatroban

Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Veralox Therapeutics

    lead INDUSTRY

Principal Investigators

  • Allen Hunt, MBA · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2022-04-01
Completion
2022-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05325346 on ClinicalTrials.gov