NCT05238493

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

A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101 Administered Intravenously or Subcutaneously in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Veloxis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VEL-101	Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1
DRUG	Placebo	Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Timeline

• Start date: 2022-04-26
• Primary completion: 2023-01-03
• Completion: 2023-01-03
• First posted: 2022-02-14
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study