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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEGIFNα1b 1.5 μg/kg | Experimental | 8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
|
| PEGIFNα1b 3.0 μg/kg | Experimental | 8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
|
| PEGIFNα1b 5.0μg/kg | Experimental | 8 randomized participants receive one dose PEGIFNα1b 5.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
|
| PEGIFNα1b 6.0 μg/kg | Experimental | 8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
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| PEGIFNα1b 7.0 μg/kg | Experimental | 8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGIFNα1b | Drug | 100μg/vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured. | receive PEGIFNα1b (day 1) to day 28 |
| λz | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15. |
| Tmax | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15. |
| Peak Plasma Concentration (Cmax) | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15. |
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15 |
| ADA | ADA in plasma of participants for immunogenicity assessments. | Receive PEGIFNα1b/placebo (day 1) to day21. |
| Nab | Nab in plasma of participants for immunogenicity assessments. | Receive PEGIFNα1b/placebo (day 1) to day21. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Neopterin | Plasma concentration of 2',5'-OAS(Type I,II), Neopterin | Receive PEGIFNα1b/placebo (day 1) to day15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanghai Institute Of Biological Products Co., Ltd | SINOPHARM | Study Director |
| The first affiliated hospital of bengbu medical college | Bengbu medical college | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Placebo | Drug | 0.5ml/vial |
|
| D007239 | Infections |