A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101
A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101
NCT ID: NCT05238493 Phase: PHASE1 Status: COMPLETED Enrollment: 60 Completion: 2023-01-03
Conditions
Healthy Volunteers
Interventions
VEL-101, Placebo
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 with Treatment-emergent Adverse Events (TEAEs)