Healthy VolunteersPhase 1NCT01901198
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers
A Phase 1 study testing Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. and Peginterferon 180 mcg single dose S.C. in people with Healthy Volunteers, run by Beijing Bio-Fortune Ltd. at 1 site in China.
Trial summary
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. and Peginterferon 180 mcg single dose S.C.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2013
- 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
- Must be healthy males or females between 18 to 45 years old, inclusive
- Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg
Who cannot join
- History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
- Female subjects who are pregnant or breastfeeding
- Any previous treatment with Human Albumin Interferon fusion protein
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Healthy Volunteers
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.
Read the detailed description
This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.
- Conditions
- Healthy Volunteers
- Being tested
- Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C., Peginterferon 180 mcg single dose S.C.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.Biological
Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0
Peginterferon 180 mcg single dose S.C.Biological
Pegasys 180 mcg S.C. single dose on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Human Serum Albumin/interferon alpha2a | Experimental | Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. Receives: Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. |
| Pegasys | Active comparator | Peginterferon 180 mcg single dose S.C. Receives: Biological: Peginterferon 180 mcg single dose S.C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events after single dose
Measured: 4 weeks
Secondary outcomes (2)
Plasma concentration of interferon after single dose
Measured: 4 weeks
Plasma concentration of Neopterin after single dose
Measured: 4 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Bio-Fortune Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, MD, Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901198
- Sponsor's protocol ID
- 921301
- Status last verified
- Nov 2014
- First submitted
- 9 Apr 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01901198
- Acronym / sponsor ID
- 921301
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Beijing Bio-Fortune Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jul 2013 (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 will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.
Detailed description
This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Serum Albumin/interferon alpha2a | Experimental | Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. |
| Pegasys | Active comparator | Biological: Peginterferon 180 mcg single dose S.C.Peginterferon 180 mcg single dose S.C. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be healthy males or females between 18 to 45 years old, inclusive
- Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg
Key exclusion criteria (4 listed)
- History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
- Female subjects who are pregnant or breastfeeding
- Any previous treatment with Human Albumin Interferon fusion protein
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0 | Biological | Human Serum Albumin/interferon alpha2a |
| Peginterferon 180 mcg single dose S.C.Pegasys 180 mcg S.C. single dose on Day 0 | Biological | Pegasys |
Primary outcome
Number of participants with adverse events after single dose
Time frame: 4 weeks
2 secondary outcomes
Plasma concentration of interferon after single dose
Time frame: 4 weeks
Plasma concentration of Neopterin after single dose
Time frame: 4 weks
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 17 Nov 2014.
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Screening Protocol
Pain
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.
Ning Li, MD principal investigator
Beijing YouAn 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 Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. and Peginterferon 180 mcg single dose S.C. in people with Healthy Volunteers, run by Beijing Bio-Fortune 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 2 inclusion and 4 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 17 Nov 2014. 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 participants with adverse events after single dose (time frame: 4 weeks). 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 17 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.