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NCT05238493 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101
A Phase 1 study, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05238493: Completed Phase 1 study, sponsored by Veloxis Pharmaceuticals.
NCT05238493 is a Phase 1 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05238493, a Phase 1 study, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study is primarily designed to assess the safety and tolerability of single doses of VEL-101 when administered subcutaneously (via injection into an area under the skin) or intravenously (via infusion into a vein). As each new group of participants is enrolled into the study, the dose administered to that group may be higher than a previous dose shown to be safe in other participants. The study is also designed to determine blood levels of VEL-101 and some substances produced by the immune system following VEL-101 administration. This information can provide insight into how quickly VEL-101 is eliminated from the body and some if its effects on the body.
Primary Outcome
Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after initiation of investigational product (IP) dosing
Interventions
- DRUG Placebo
- DRUG VEL-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-04-26 |
| Est. Completion | 2023-01-03 |
| Phase | Phase 1 |
What the finished NCT05238493 record still lists
NCT05238493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05238493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05238493 about?
NCT05238493 is a clinical study titled "A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101". This study is primarily designed to assess the safety and tolerability of single doses of VEL-101 when administered subcutaneously (via injection into an area under the skin) or intravenously (via infusion into a vein). As each new group of participants is enrolled into the study, the dose administe...
What is the current status of trial NCT05238493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-04-26. Estimated completion is 2023-01-03.
What interventions are being tested in trial NCT05238493?
The interventions under investigation include: Placebo (DRUG), VEL-101 (DRUG).
Who is sponsoring clinical trial NCT05238493?
This trial is sponsored by Veloxis Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05238493's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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