Healthy SubjectsPhase 1NCT01343186
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects
A Phase 1 study testing Peginterferon alfa, Peginterferon alfa 2a and Peginterferon alfa-2a in people with Healthy Subjects, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
Trial summary
This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Peginterferon alfa, Peginterferon alfa 2a and Peginterferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Nov 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Age between 18 and 45, inclusive
- Body mass index(BMI)between 19 and 26, inclusive
- Sign informed consent
Who cannot join
- Women of pregnant or lactation
- Known hypersensitivity to interferon or any other components of the study drug
- History of mental disease or genetic disease
- History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant
- Significant disease in heart, liver, kidney, lung or any other major organs
- Alcoholic, smokers or drug abusers
- Blood donation, or massive blood loss due to injury or surgery within 3 months
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects
This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.
- Conditions
- Healthy Subjects
- Being tested
- Peginterferon alfa, Peginterferon alfa 2a, Peginterferon alfa-2a
- Keywords
- Peginterferon, Healthy subject, Pharmacokinetics, Pharmacodynamics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfaDrug
s,c, 45mcg of Ypeginterferon alfa-2a
Peginterferon alfa 2aDrug
s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Peginterferon alfa-2aDrug
s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Peginterferon alfa-2aDrug
s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Peginterferon alfa |
| Arm 2 | Other | Not described Receives: Drug: Peginterferon alfa 2a |
| Arm 3 | Other | Not described Receives: Drug: Peginterferon alfa-2a |
| Arm 4 | Other | Not described Receives: Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring interferon levels in blood samples
Measured: from 0 to 408 hours following injection
Different blood interferon biomarkers (such as 2,5-OAS, neopterin)
Measured: from 0 to 408 hours following injection
Secondary outcomes (2)
Adverse events
Measured: up to 3 weeks following injection
Anti-interferon antibody
Measured: baseline and week 2 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhenman, Ph.D, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343186
- Sponsor's protocol ID
- TB1012IFN
- Status last verified
- Dec 2010
- First submitted
- 24 Apr 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01343186
- Acronym / sponsor ID
- TB1012IFN
- Conditions
- Healthy Subjects
- Keywords
- Peginterferon, Healthy subject, Pharmacokinetics, Pharmacodynamics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Apr 2011 (estimated)
- 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 study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Peginterferon alfa |
| Arm 2 | Other | Drug: Peginterferon alfa 2a |
| Arm 3 | Other | Drug: Peginterferon alfa-2a |
| Arm 4 | Other | Drug: Peginterferon alfa-2a |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- Age between 18 and 45, inclusive
- Body mass index(BMI)between 19 and 26, inclusive
- Sign informed consent
Key exclusion criteria (8 listed)
- Women of pregnant or lactation
- Known hypersensitivity to interferon or any other components of the study drug
- History of mental disease or genetic disease
- History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant
- Significant disease in heart, liver, kidney, lung or any other major organs
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 |
|---|---|---|
| Peginterferon alfas,c, 45mcg of Ypeginterferon alfa-2a | Drug | Arm 1 |
| Peginterferon alfa 2as,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys. | Drug | Arm 2 |
| Peginterferon alfa-2as,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys. | Drug | Arm 3 |
| Peginterferon alfa-2as,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys. | Drug | Arm 4 |
Primary outcome
Measuring interferon levels in blood samples
Time frame: from 0 to 408 hours following injection
Different blood interferon biomarkers (such as 2,5-OAS, neopterin)
Time frame: from 0 to 408 hours following injection
2 secondary outcomes
Adverse events
Time frame: up to 3 weeks following injection
Anti-interferon antibody
Time frame: baseline and week 2 after injection
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 31 Jan 2012.
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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.
Wei Zhenman, Ph.D principal investigator
Beijing 302 Hospital
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 Peginterferon alfa, Peginterferon alfa 2a and Peginterferon alfa-2a in people with Healthy Subjects, run by Xiamen Amoytop Biotech Co., Ltd. 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 8 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 31 Jan 2012. 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?
Measuring interferon levels in blood samples (time frame: from 0 to 408 hours following injection). The study lists 2 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 31 Jan 2012.