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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Number of adverse events
The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured.
Time frame: receive PEGIFNα1b (day 1) to day 28
λz
Pharmacokinetic assessments
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15.
Tmax
Pharmacokinetic assessments
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15.
Peak Plasma Concentration (Cmax)
Pharmacokinetic assessments
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15.
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic assessments
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15
ADA
ADA in plasma of participants for immunogenicity assessments.
Time frame: Receive PEGIFNα1b/placebo (day 1) to day21.
Nab
Nab in plasma of participants for immunogenicity assessments.
Time frame: Receive PEGIFNα1b/placebo (day 1) to day21.
Level of Neopterin
Plasma concentration of 2',5'-OAS(Type I,II), Neopterin
Time frame: Receive PEGIFNα1b/placebo (day 1) to day15
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