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A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects
Phase 1
Waitlist Available
Led By Allen Hunt, MBA
Research Sponsored by Veralox Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 - 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial tests a new drug, VLX-1005, alone and with another drug, in healthy individuals. It aims to ensure safety and understand how these drugs interact. The goal is to see how they work in the body and their effects, focusing on safety and bleeding risks.
Eligible Conditions
- Heparin Induced Thrombocytopenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 - 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 - 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effects of VLX-1005 on AUC(inf) of argatroban
Effects of VLX-1005 on Cmax of argatroban
Effects of VLX-1005 on PFA-100
+7 moreSecondary study objectives
Effects of VLX-1005 on 12-HETE
Effects of argatroban on 12-HETE
Safety as measured by incidence of Treatment Emergent Adverse Events
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: VLX-1005 and ArgatrobanExperimental Treatment2 Interventions
Intravenous co-administration of VLX-1005 and argatroban with measurements of PK and PD
Group II: VLX-1005Experimental Treatment1 Intervention
Intravenous administration of VLX-1005 with measurements of PK and PD
Group III: ArgatrobanActive Control1 Intervention
Intravenous administration of argatroban with measurements of PK and PD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Argatroban
FDA approved
VLX-1005
2022
Completed Phase 1
~110
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Veralox TherapeuticsLead Sponsor
2 Previous Clinical Trials
156 Total Patients Enrolled
CelerionIndustry Sponsor
84 Previous Clinical Trials
7,918 Total Patients Enrolled
Allen Hunt, MBAPrincipal InvestigatorCelerion