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A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639803
Recruitment Status : Completed
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute Of Biological Products

Brief 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.


Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: PEGIFNα1b Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I,Randomized, Double-blind,Placebo Controlled,Dose Escalated, Single Adminstrated Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
Actual Study Start Date : July 7, 2020
Actual Primary Completion Date : October 22, 2020
Actual Study Completion Date : October 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: PEGIFNα1b 1.5 μg/kg
8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered
Drug: PEGIFNα1b
100μg/vial

Drug: Placebo
0.5ml/vial

Experimental: PEGIFNα1b 3.0 μg/kg
8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered
Drug: PEGIFNα1b
100μg/vial

Drug: Placebo
0.5ml/vial

Experimental: PEGIFNα1b 5.0μg/kg
8 randomized participants receive one dose PEGIFNα1b 5.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered
Drug: PEGIFNα1b
100μg/vial

Drug: Placebo
0.5ml/vial

Experimental: PEGIFNα1b 6.0 μg/kg
8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered
Drug: PEGIFNα1b
100μg/vial

Drug: Placebo
0.5ml/vial

Experimental: PEGIFNα1b 7.0 μg/kg
8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered
Drug: PEGIFNα1b
100μg/vial

Drug: Placebo
0.5ml/vial




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: receive PEGIFNα1b (day 1) to day 28 ]
    The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured.

  2. λz [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day 15. ]
    Pharmacokinetic assessments

  3. Tmax [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day 15. ]
    Pharmacokinetic assessments

  4. Peak Plasma Concentration (Cmax) [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day 15. ]
    Pharmacokinetic assessments

  5. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day 15 ]
    Pharmacokinetic assessments

  6. ADA [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day21. ]
    ADA in plasma of participants for immunogenicity assessments.

  7. Nab [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day21. ]
    Nab in plasma of participants for immunogenicity assessments.


Secondary Outcome Measures :
  1. Level of Neopterin [ Time Frame: Receive PEGIFNα1b/placebo (day 1) to day15 ]
    Plasma concentration of 2',5'-OAS(Type I,II), Neopterin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must agree to and voluntarily sign a written Informed Consent prior to the study.
  • Must be healthy males or females.
  • Between 18 to 70 years old, inclusive.
  • Must have a body mass index (BMI) of 19 to 26 kg/m2, inclusive, and male subject must have a minimum body weight of 50.0 kg,female subject must have a minimum body weight of 45kg.

Exclusion Criteria:

  • History of allergic or anaphylactic reactions or known allergy to any component of interferon medication including the study drug.
  • Having abnormality in physical examination,vital signs, electrocardiogram,eye,skin(e.g., psoriasis,sarcoidosis) within screening and the abnormality is considered clinically significant as determined by the investigator.
  • Laboratory values (platelet, hemoglobin or neutrophils)that were outside the normal range,ALT,AST or TG>1.5 fold normal range,positive test result for pregnancy,hepatitis B surface antigen(HBsAg) ,hepatitis C antibody (HCV Ab),treponema pallidum antibody or human immunodeficiency virus antibody(HIV Ab), thyroid function abnormal within screening.
  • Having any ischemic disease,autoimmune disease,infectious disorders,history of neuropsychiatric disease (e.g., epilepsy,depression,suicidal behavior).
  • History of any disease (gastrointestinal tract,renal,hepatic,neurologic,hematologic,endocrinologic, tumor, pulmonary, cardiovascular and/or other major disease), or organ transplantation within 6 months prior to screening.
  • Unlikely to comply with unified diet or having difficulty to swallow.
  • Treatment with any medication( prescription/nonpreserip drugs/vitamins/herbs ) within 30 days prior to screening.
  • History of alcohol abuse (more than 14 units of alcohol per week, one unit of alcohol equals 360ml beer or 150ml wine or 45ml strong drinks containing 40% alcohol) within 3 months prior to screening or a positive screen test for presence for alcohol at screening or into hospital.
  • Consuming any special diet(including dragon fruit,mango,grapefruit,etc. ) or doing strenuous exercise within 2 weeks prior to screening. Consuming alcohol or caffeine containing products(e.g., coffee,tea, coco,chocolate ) within 48 hours of dosing. Intaking any products can affecting drug absorption,distribution,excretion,metabolism.
  • Regular smoking with consumption ≥ 5 cigarettes per day winthin 3 months prior to screening.
  • Treatment with any interferon product within 6 months prior to screening.
  • Participation in any other medication or device study within 3 months prior to screening.
  • History of drug (morphine,marihuana,methamphetamine,dimethylamphetamine,ketamine,etc.) abuse or a positive screen test for presence for drugs.
  • Having donated or lost 200 mL or more of blood within 3 months prior to screening or plan to donate blood throughout the study and within 3 months after the study.
  • Lactating mothers,male subjects(or pairs) and female subjects have child-bearing/sperm or egg donation plan from 30 days before study to 3 months after study while unwill to practice effective birth control throughout the study.
  • History of blood or needle phobia.
  • Driving or operating delicated machinery throughout the study.
  • Investigator discretion as to unsuitability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639803


Locations
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China, Anhui
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Sponsors and Collaborators
Shanghai Institute Of Biological Products
Investigators
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Study Director: Shanghai Institute Of Biological Products Co., Ltd SINOPHARM
Principal Investigator: The first affiliated hospital of bengbu medical college Bengbu medical college
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Responsible Party: Shanghai Institute Of Biological Products
ClinicalTrials.gov Identifier: NCT05639803    
Other Study ID Numbers: SH-002-01
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Institute Of Biological Products:
Peginterferon α1b for Injection
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections