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A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101

Phase 1
Waitlist Available
Research Sponsored by Veloxis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days -1, 1 (0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 16, 20 hours), 2 (24, 30, 36, 42 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50

Summary

This trial tests VEL-101, a drug given by injection or infusion, to see if it is safe and well-tolerated. It involves general participants, likely including healthy volunteers. Researchers will measure how the body handles the drug and its effects on immune substances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days -1, 1 (0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 16, 20 hours), 2 (24, 30, 36, 42 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and days -1, 1 (0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 16, 20 hours), 2 (24, 30, 36, 42 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and Percentage of Participants with Grade 3 or Higher TEAEs
Number and Percentage of Participants with Serious TEAEs
Number and Percentage of Participants with TEAEs Leading to Death
+2 more
Secondary study objectives
AUC from Time Zero to Infinity
Area Under the Plasma Concentration Versus Time Curve (AUC) from Time Zero to Time of Last Observed Quantifiable Concentration
Bioavailability (F)
+15 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Subcutaneous (SQ) Dose "A"Experimental Treatment1 Intervention
Single dose of VEL-101 by SQ injection
Group II: SQ Dose "E"Experimental Treatment1 Intervention
Single dose of VEL-101 by SQ injection
Group III: SQ Dose "D"Experimental Treatment1 Intervention
Single dose of VEL-101 by SQ injection
Group IV: SQ Dose "C"Experimental Treatment1 Intervention
Single dose of VEL-101 by SQ injection
Group V: SQ Dose "B"Experimental Treatment1 Intervention
Single dose of VEL-101 by SQ injection
Group VI: Intravenous (IV) Dose "A"Experimental Treatment1 Intervention
Single dose of VEL-101 by IV infusion
Group VII: IV Dose "C"Experimental Treatment1 Intervention
Single dose of VEL-101 by IV infusion
Group VIII: SQ or IV PlaceboPlacebo Group1 Intervention
Single dose of Placebo by SQ injection or IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VEL-101
2022
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Veloxis PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
3,010 Total Patients Enrolled
Libbie McKenzie, MDStudy DirectorVeloxis Pharmaceuticals
Shailesh G. Chavan, MDStudy DirectorVeloxis Pharmaceuticals
1 Previous Clinical Trials
77 Total Patients Enrolled
~17 spots leftby Dec 2025
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