HealthyPhase 1NCT02781753
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers
A Phase 1 study testing Human Serum Albumin/interferon alpha2b and Peginterferon 180 μg single dose S.C. in people with Healthy, run by Tianjin SinoBiotech Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Human Serum Albumin/interferon alpha2b and Peginterferon 180 μg 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
- 7 Apr 2016to 12 Apr 2017
- 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
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 alpha2b Fusion Protein in Healthy Chinese Volunteers
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.
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 alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b 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
- Being tested
- Human Serum Albumin/interferon alpha2b, Peginterferon 180 μg 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 alpha2bBiological
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0
Peginterferon 180 μg 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 alpha2b | Experimental | Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. Receives: Biological: Human Serum Albumin/interferon alpha2b |
| Pegasys | Active comparator | Peginterferon 180 μg single dose S.C. Receives: Biological: Peginterferon 180 μg 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
Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events.
Measured: 4 weeks
Secondary outcomes (5)
Pharmacokinetics of interferon after single dose
Peak plasma concentration(Cmax)
Measured: 4 weeks
Pharmacokinetics of interferon after single dose
Area under the plasma concentration versus time curve (AUC)
Measured: 4 weeks
Plasma concentration of Neopterin after single dose
Plasma concentration of Neopterin after single dose
Measured: 4 weeks
Pharmacokinetics of interferon after single dose
Peak time(Tmax)
Measured: 4 weeks
Pharmacokinetics of interferon after single dose
Half-life period(T1/2)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start7 Apr 2016
- Primary completion2 Aug 2016
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Tianjin SinoBiotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meixia Wang, Professor, Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781753
- Sponsor's protocol ID
- 921601
- Status last verified
- Apr 2017
- First submitted
- 20 May 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. 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 alpha2b Fusion Protein in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT02781753
- Acronym / sponsor ID
- 921601
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tianjin SinoBiotech Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 2 Aug 2016 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 24 May 2016 (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.
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.
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 alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b 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 alpha2b | Experimental | Biological: Human Serum Albumin/interferon alpha2bHuman Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. |
| Pegasys | Active comparator | Biological: Peginterferon 180 μg single dose S.C.Peginterferon 180 μg 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 (3 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
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 alpha2bHuman Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0 | Biological | Human Serum Albumin/interferon alpha2b |
| Peginterferon 180 μg 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
Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events.
5 secondary outcomes
Pharmacokinetics of interferon after single dose
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Time frame: 4 weeks
Plasma concentration of Neopterin after single dose
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Time frame: 4 weeks
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 8 May 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Meixia Wang, Professor 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 alpha2b and Peginterferon 180 μg single dose S.C. in people with Healthy, run by Tianjin SinoBiotech 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 3 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 8 May 2017. 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 8 May 2017.