A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

NCT05639803 | Completed Phase 1

• 1 other identifier: SH-002-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

Peginterferon α1b for Injection

Outcome Measures

Primary Outcomes (7)

• 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.

Secondary Outcomes (1)

• Level of Neopterin

  Receive PEGIFNα1b/placebo (day 1) to day15

Study Arms (5)

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

Drug: PEGIFNα1b; Drug: Placebo

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

Drug: PEGIFNα1b; Drug: Placebo

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

Drug: PEGIFNα1b; Drug: Placebo

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

Drug: PEGIFNα1b; Drug: Placebo

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

Drug: PEGIFNα1b; Drug: Placebo

Interventions

PEGIFNα1b DRUG

100μg/vial

PEGIFNα1b 1.5 μg/kg; PEGIFNα1b 3.0 μg/kg; PEGIFNα1b 5.0μg/kg; PEGIFNα1b 6.0 μg/kg; PEGIFNα1b 7.0 μg/kg

Placebo DRUG

0.5ml/vial

PEGIFNα1b 1.5 μg/kg; PEGIFNα1b 3.0 μg/kg; PEGIFNα1b 5.0μg/kg; PEGIFNα1b 6.0 μg/kg; PEGIFNα1b 7.0 μg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Study Officials

• Shanghai Institute Of Biological Products Co., Ltd

  SINOPHARM

  STUDY DIRECTOR

• The first affiliated hospital of bengbu medical college

  Bengbu medical college

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: December 6, 2022
• Study Start: July 7, 2020
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

CN (1)