A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
- Registration Number
- NCT05639803
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEGIFNα1b 1.5 μg/kg Placebo 8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered PEGIFNα1b 1.5 μg/kg PEGIFNα1b 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 PEGIFNα1b 8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered PEGIFNα1b 7.0 μg/kg PEGIFNα1b 8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered PEGIFNα1b 3.0 μg/kg Placebo 8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered PEGIFNα1b 5.0μg/kg Placebo 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 Placebo 8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered PEGIFNα1b 7.0 μg/kg Placebo 8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered PEGIFNα1b 5.0μg/kg PEGIFNα1b 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 PEGIFNα1b 8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) Receive PEGIFNα1b/placebo (day 1) to day 15. Pharmacokinetic assessments
ADA Receive PEGIFNα1b/placebo (day 1) to day21. ADA in plasma of participants for immunogenicity assessments.
Tmax Receive PEGIFNα1b/placebo (day 1) to day 15. Pharmacokinetic assessments
Number of adverse events receive PEGIFNα1b (day 1) to day 28 The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured.
λz Receive PEGIFNα1b/placebo (day 1) to day 15. Pharmacokinetic assessments
Area under the plasma concentration versus time curve (AUC) Receive PEGIFNα1b/placebo (day 1) to day 15 Pharmacokinetic assessments
Nab Receive PEGIFNα1b/placebo (day 1) to day21. Nab in plasma of participants for immunogenicity assessments.
- Secondary Outcome Measures
Name Time Method Level of Neopterin Receive PEGIFNα1b/placebo (day 1) to day15 Plasma concentration of 2',5'-OAS(Type I,II), Neopterin
Trial Locations
- Locations (1)
The first affiliated hospital of bengbu medical college
🇨🇳Bengbu, Anhui, China