A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

Shanghai Institute Of Biological Products

Status and phase: Completed; Phase 1

Conditions: Herpes Zoster

Treatments: Drug: PEGIFNα1b; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05639803

SH-002-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups

PEGIFNα1b 1.5 μg/kg

Experimental group

Description:

8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered

Treatment:

Drug: Placebo

Drug: PEGIFNα1b

PEGIFNα1b 3.0 μg/kg

Experimental group

Description:

8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered

Treatment:

Drug: Placebo

Drug: PEGIFNα1b

PEGIFNα1b 5.0μg/kg

Experimental group

Description:

8 randomized participants receive one dose PEGIFNα1b 5.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered

Treatment:

Drug: Placebo

Drug: PEGIFNα1b

PEGIFNα1b 6.0 μg/kg

Experimental group

Description:

8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered

Treatment:

Drug: Placebo

Drug: PEGIFNα1b

PEGIFNα1b 7.0 μg/kg

Experimental group

Description:

8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered

Treatment:

Drug: Placebo

Drug: PEGIFNα1b