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VEL-101 for Healthy Subjects

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
Body mass index (BMI) within the range of 18.5 to <35 kg/m2 at Screening;
Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent;
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
Awards & highlights

Study Summary

This trial is assessing the safety and tolerability of VEL-101 given in different doses and ways. It will also look at how the body processes the drug and its effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
3,086 Total Patients Enrolled
Libbie McKenzie, MDStudy DirectorVeloxis Pharmaceuticals
Shailesh G. Chavan, MDStudy DirectorVeloxis Pharmaceuticals
1 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below 25 years old qualified to register for this medical trial?

"Participants of this trial must fall within the ages 18 to 65. Additionally, there are 50 studies available for minors and 373 trials targeting those above retirement age."

Answered by AI

Could I be considered a participant in this investigatory program?

"This medical trial is recruiting a cohort of 56 healthy adults, aged 18 to 65 years old. To be accepted into the study they must comprehend fully the contents conveyed in the informed consent form, present with a BMI between 18.5 and 35 kg/m2 at screening, maintain contraceptive use for 50 days after dosing if applicable and demonstrate an ability to adhere rigorously to all necessary procedures including overnight stays at clinical centres and dietary restrictions during the duration of the research."

Answered by AI

Is this research currently in need of volunteers?

"According to the clinicaltrials.gov listing, this trial is actively seeking participants since its inception on April 26th 2022 and subsequent updates through November 1st 2022."

Answered by AI

What potential hazards does VEL-101 pose to individuals?

"VEL-101's safety has been assessed as a 1 on our 3 point scale, due to the fact that it is still in Phase 1 clinical trials. This implies there are limited data available concerning its efficacy and safety."

Answered by AI

What is the maximum capacity of participants in this experiment?

"Indeed, the clinicaltrials.gov page reveals that this study is in progress and accepting applicants. It was first advertised on April 26th 2022 and has since undergone its most recent update on November 1st 2022. This trial requires 56 participants to be recruited from a single medical centre."

Answered by AI

What positive results are researchers expecting from this experiment?

"This clinical trial will measure its primary outcome, the Number and Percentage of Participants with TEAEs Leading to Death between Day 1 and Day 50. Secondary metrics encompass Terminal Elimination Half-life, Total Clearance (CL), and AUC from Time Zero to Infinity."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
CTI Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
~21 spots leftby Mar 2025