Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT05806918
Eligibility Criteria:
Main Inclusion Criteria:
1. Men and women aged between 18 and 70 years old.
2. Diagnosed as herpes zoster.
3. Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA).
4. Self-rated Numerical Rating Scale (NRS) in pain ≤ 6.
5. Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age.
6. Subjects must have signed an informed consent form (ICF).
Main Exclusion Criteria:
1. Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis.
2. The lesion is complicated with other skin diseases that may affect the evaluation of efficacy,
3. Skin lesions combined with severe bacterial or fungal infections.
4. Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing.
5. Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy.
6. Liver and/or renal disfunction，ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) \> 2 times of upper normal limit（ULN）; Creatinine Clearance Rate (CCR) \< 50 L/min.
7. Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs.
8. Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment.
9. History of psychiatric illness or inability to fully comply to the protocol.
10. Use of another investigational product within 4 weeks prior to the first dosing.
11. Pregnant or lactating women.
12. Other conditions deemed by the investigator to be inappropriate for participation in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05806918
Study Brief:
Protocol Section:
NCT05806918