drugset / Trial / NCT03047317
A Pharmacokinetic Study of MABp1 in Healthy Volunteers
NaSingle-groupOpen-labelTreatment
Summary
This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In addition to pharmacokinetic data, participants will be monitored for the development of treatment emergent adverse events.
Timeline
- Start
- 2017-02-15
- Primary completion
- 2017-03-08
- Completion
- 2017-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bermekimab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
Indications
No indication recorded.