A Phase I Study in Healthy Participants

Phase 1 Completed 35 enrolled Kexing Biopharm Co., Ltd. Beijing SSYP Data Technology Development Co.,Ltd. · collab Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. · collab The Third Hospital of Changsha · collab United-Power Pharma Tech（Shanghai）Co., Ltd. · collab

RandomizedSequentialQuadruple-blindTreatment

Summary

A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses

Timeline

Start: 2023-01-07
Primary completion: 2023-04-21
Completion: 2023-04-21

Publications

Peng H, Zhang W, Lin Y, Li H, Qin S. Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNalpha1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers. Infect Dis Ther. 2024 Sep;13(9):2053-2070. doi: 10.1007/s40121-024-01024-y. Epub 2024 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GB05	Unknown	200000 iu	Inhaled
Subject	GB05	Unknown	600000 iu	Inhaled
Subject	GB05	Unknown	1.2e+06 iu	Inhaled
Subject	GB05	Unknown	1.8e+06 iu	Inhaled

Indications

No indication recorded.