drugset / Trial / NCT03227796
Safety, Tolerability & Pharmacokinetics of LEVI-04 in Healthy Volunteers and Patients With Osteoarthritis Knee Pain
Phase 1
Completed
56 enrolled
Levicept
Hammersmith Medicines Research · collabMAC Clinical Research · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain attributed to osteoarthritis of the knee)
Timeline
- Start
- 2017-07-28
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LEVI-04 | Protein / enzyme biologic | 0.003 mg/kg | Intravenous |
| Subject | LEVI-04 | Protein / enzyme biologic | 0.01 mg/kg | Intravenous |
| Subject | LEVI-04 | Protein / enzyme biologic | 0.03 mg/kg | Intravenous |
| Subject | LEVI-04 | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | LEVI-04 | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | LEVI-04 | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | LEVI-04 | Protein / enzyme biologic | 3 mg/kg | Intravenous |