A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

• ClinicalTrials.gov Identifier: NCT05639803
• Recruitment Status: Completed
• First Posted: December 6, 2022
• Last Update Posted: December 6, 2022
• Sponsor: Shanghai Institute Of Biological Products
• Information provided by (Responsible Party): Shanghai Institute Of Biological Products

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

China, Anhui

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Sponsors and Collaborators

Shanghai Institute Of Biological Products

Investigators

• Study Director: Shanghai Institute Of Biological Products Co., Ltd; SINOPHARM
• Principal Investigator: The first affiliated hospital of bengbu medical college; Bengbu medical college

More Information

• Responsible Party: Shanghai Institute Of Biological Products
• ClinicalTrials.gov Identifier: NCT05639803
• Other Study ID Numbers: SH-002-01
• First Posted: December 6, 2022
• Last Update Posted: December 6, 2022
• Last Verified: November 2022

• 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:

Herpes Zoster; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections