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

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.

Timeline

Start

2022-04-26

Primary completion

2023-01-03

Completion

2023-01-03

Publications

• Tremblay S, Abaigar A, Allton P, Sardinha D, Patel SJ, Shah K, Maynard J, Otulana B. Safety, Pharmacokinetics, and Pharmacodynamics of Fixed-dose, Subcutaneous, and Intravenous Administration of VEL-101, an Anti-CD28 PEGylated Monoclonal Antibody Fragment, in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, Dose Escalation, Phase 1 Study. Transplantation. 2026 Jun 1;110(6):e1308-e1316. doi: 10.1097/TP.0000000000005701. Epub 2026 May 4.

Drugs

Indications

No indication recorded.