Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Phase 1 Completed 48 enrolled PharmaEssentia

RandomizedSequentialDouble-blindOther

Summary

This was a single-center, double-blind, randomized, active control, single dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of P1101 in 48 healthy volunteers.

Timeline

Start: 2009-11-07
Primary completion: 2010-06-26
Completion: 2010-06-26

Publications

Results Huang YW, Qin A, Fang J, Wang TF, Tsai CW, Lin KC, Teng CL, Larouche R. Novel long-acting ropeginterferon alfa-2b: Pharmacokinetics, pharmacodynamics and safety in a phase I clinical trial. Br J Clin Pharmacol. 2022 May;88(5):2396-2407. doi: 10.1111/bcp.15176. Epub 2021 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ropeginterferon alfa-2b	Protein / enzyme biologic	24 ug	Subcutaneous
Subject	Ropeginterferon alfa-2b	Protein / enzyme biologic	48 ug	Subcutaneous
Subject	Ropeginterferon alfa-2b	Protein / enzyme biologic	90 ug	Subcutaneous
Subject	Ropeginterferon alfa-2b	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ropeginterferon alfa-2b	Protein / enzyme biologic	225 ug	Subcutaneous
Subject	Ropeginterferon alfa-2b	Protein / enzyme biologic	270 ug	Subcutaneous

Indications

No indication recorded.