NCT05639803

A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

A Phase I，Randomized, Double-blind，Placebo Controlled，Dose Escalated, Single Adminstrated Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I，randomized, double-blind, placebo controlled,dose escalated,single administrated clinical trial in Chinese healthy adult's volunteers. In the trial, it is planned to enroll 50 subjects, randomized to 5 dosage groups to receive the test drug and the placebo control.

Detailed description

This study is a randomized, double-blind, placebo-controlled, dose-escalation, single-dose phase I clinical study, including safety tolerability assessment, pharmacokinetic studies and immunogenicity studies, to evaluate the expression level of mRNA in whole blood of 2',5'-oligoadenylate synthetase, as well as the level of Neopterin (NTP) in serum.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
DRUG	PEGIFNα1b	100μg/vial
DRUG	Placebo	0.5ml/vial

Timeline

• Start date: 2020-07-07
• Primary completion: 2020-10-22
• Completion: 2020-10-22
• First posted: 2022-12-06
• Last updated: 2022-12-06

Locations

1 site across 1 country: China