drugset / Trial / NCT01504581
Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study design: This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.
Timeline
- Start
- 2011-03
- Primary completion
- 2011-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HM10660A | Protein / enzyme biologic | 1.5 ug/kg | — |
| Subject | HM10660A | Protein / enzyme biologic | 2.25 ug/kg | — |
| Subject | HM10660A | Protein / enzyme biologic | 3 ug/kg | — |
| Subject | HM10660A | Protein / enzyme biologic | 4 ug/kg | — |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | — |
Indications
No indication recorded.