Herpes ZosterPhase 1NCT05639803
A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
A Phase 1 study testing PEGIFNα1b in people with Herpes Zoster, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- PEGIFNα1b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2020to 22 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of bengbu medical college
Bengbu, Anhui
About this study
Official title: A Phase I，Randomized, Double-blind，Placebo Controlled，Dose Escalated, Single Adminstrated Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
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.
Read the 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.
- Conditions
- Herpes Zoster
- Being tested
- PEGIFNα1b, Placebo
- Keywords
- Peginterferon α1b for Injection
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGIFNα1bDrug
100μg/vial
PlaceboDrug
0.5ml/vial
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: PEGIFNα1b; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured.
Measured: receive PEGIFNα1b (day 1) to day 28
λz
Pharmacokinetic assessments
Measured: Receive PEGIFNα1b/placebo (day 1) to day 15.
Tmax
Pharmacokinetic assessments
Measured: Receive PEGIFNα1b/placebo (day 1) to day 15.
Peak Plasma Concentration (Cmax)
Pharmacokinetic assessments
Measured: Receive PEGIFNα1b/placebo (day 1) to day 15.
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic assessments
Measured: Receive PEGIFNα1b/placebo (day 1) to day 15
ADA
ADA in plasma of participants for immunogenicity assessments.
Measured: Receive PEGIFNα1b/placebo (day 1) to day21.
Nab
Nab in plasma of participants for immunogenicity assessments.
Measured: Receive PEGIFNα1b/placebo (day 1) to day21.
Secondary outcomes (1)
Level of Neopterin
Plasma concentration of 2',5'-OAS(Type I,II), Neopterin
Measured: Receive PEGIFNα1b/placebo (day 1) to day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start7 Jul 2020
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanghai Institute Of Biological Products Co., Ltd, Study director, SINOPHARMThe first affiliated hospital of bengbu medical college, Principal investigator, Bengbu medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639803
- Sponsor's protocol ID
- SH-002-01
- Status last verified
- Nov 2022
- First submitted
- 16 Jun 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I，Randomized, Double-blind，Placebo Controlled，Dose Escalated, Single Adminstrated Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
- ClinicalTrials.gov ID
- NCT05639803
- Acronym / sponsor ID
- SH-002-01
- Conditions
- Herpes Zoster
- Keywords
- Peginterferon α1b for Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PEGIFNα1b 1.5 μg/kg | Experimental | Drug: PEGIFNα1b, Drug: Placebo8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
| PEGIFNα1b 3.0 μg/kg | Experimental | Drug: PEGIFNα1b, Drug: Placebo8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
| PEGIFNα1b 5.0μg/kg | Experimental | Drug: PEGIFNα1b, Drug: Placebo8 randomized participants receive one dose PEGIFNα1b 5.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
| PEGIFNα1b 6.0 μg/kg | Experimental | Drug: PEGIFNα1b, Drug: Placebo8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
| PEGIFNα1b 7.0 μg/kg | Experimental | Drug: PEGIFNα1b, Drug: Placebo8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGIFNα1b100μg/vial | Drug | PEGIFNα1b 1.5 μg/kg, PEGIFNα1b 3.0 μg/kg, PEGIFNα1b 5.0μg/kg, PEGIFNα1b 6.0 μg/kg, PEGIFNα1b 7.0 μg/kg |
| Placebo0.5ml/vial | Drug | PEGIFNα1b 1.5 μg/kg, PEGIFNα1b 3.0 μg/kg, PEGIFNα1b 5.0μg/kg, PEGIFNα1b 6.0 μg/kg, PEGIFNα1b 7.0 μg/kg |
Primary outcome
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.
λz
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15.
Pharmacokinetic assessments
Tmax
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15.
Pharmacokinetic assessments
Peak Plasma Concentration (Cmax)
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15.
Pharmacokinetic assessments
Area under the plasma concentration versus time curve (AUC)
Time frame: Receive PEGIFNα1b/placebo (day 1) to day 15
Pharmacokinetic assessments
ADA
Time frame: Receive PEGIFNα1b/placebo (day 1) to day21.
ADA in plasma of participants for immunogenicity assessments.
Nab
Time frame: Receive PEGIFNα1b/placebo (day 1) to day21.
Nab in plasma of participants for immunogenicity assessments.
1 secondary outcome
Level of Neopterin
Time frame: Receive PEGIFNα1b/placebo (day 1) to day15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanghai Institute Of Biological Products Co., Ltd study director
SINOPHARM
The first affiliated hospital of bengbu medical college principal investigator
Bengbu medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEGIFNα1b in people with Herpes Zoster, run by Shanghai Institute Of Biological Products at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: receive PEGIFNα1b (day 1) to day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.