Healthy SubjectsPhase 1NCT03786289

Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection

A Phase 1 study testing Recombinant human serum albumin/erythropoietin fusion protein and Recombinant erythropoietin injection (CHO cells) in people with Healthy Subjects, run by Tianjin SinoBiotech Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary pharmacokinetic parameters. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Recombinant human serum albumin/erythropoietin fusion protein and Recombinant erythropoietin injection (CHO cells)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteChina
Study dates: 3 Dec 2018to 9 Dec 2019
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) in the range of 19.0~26.0 (including critical value) (bmi= bw (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg
Understand and sign the informed consent form

Who cannot join

Persons with allergic physique or sensitive skin;
Any person with any skin disease;
have a history of drug or food allergies, especially for the active ingredients of this product or similar drugs, mammalian cells to The source of the drug, human serum albumin or other biological agents expressed in CHO allergy;
Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;
Having a fertility plan within 2 weeks of screening and within 6 months of the end of the trial and not having to take it during the trial period

Show all 19Show fewer

Effective non-drug contraceptive measures;
Within 14 days prior to screening or within 5 half-life of the drug (whichever is the oldest of the two) there has been any Prescription drugs, over-the-counter drugs, Chinese herbal medicine, health care products medicine history;
Hemoglobin ≤130 g/L or ≥150/g (male), hemoglobin ≤115 g/L or ≥133 g/L (female version number: 1.2 Version date: September 30, 2018 26 sexual);
The percentage of erythrocyte red blood cells ≥ 3%;
ferritin <200 ng/ml (male), ferritin <80 ng/ml (female);
The use of drugs known to have damage to an organ during the first 3 months of screening;
A person who has received a blood transfusion or rhEPO treatment;
Clinically determined to be vitamin B12 or folic acid deficiency;
Have a history of dizziness and needle sickness;
A clinical trial person who has participated in other drugs within the first 3 months of screening;
Those who had lost blood or blood ≥200ml during the first 8 weeks of screening;
Women during pregnancy and lactation;
The researchers did not consider it appropriate to enter the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing you 'an hospital affiliated to capital medical university
Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage

Read the detailed description

This experiment was a single-center clinical study with randomized, open, positive drug control and single dose increment. The test group will be conducted in the order of incremental dose from 150μg to 1200μg 5 dose groups, with 1 positive control groups (EPIAO). After 7 days of administration, the researchers looked at the drug safety tolerance of the test to determine whether to proceed with the next higher dose group test.

Conditions: Healthy Subjects
Being tested: Recombinant human serum albumin/erythropoietin fusion protein, Recombinant erythropoietin injection (CHO cells)
Keywords: Recombinant human erythropoietin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant human serum albumin/erythropoietin fusion proteinBiological
Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1
Recombinant erythropoietin injection (CHO cells)Biological
Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1

Study groups in NCT03786289
Study group	Role	What they receive
Recombinant human serum albumin/erythropoietin fusion protein	Experimental	Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection Receives: Biological: Recombinant human serum albumin/erythropoietin fusion protein
Recombinant human erythropoietin injection (CHO cells)	Active comparator	Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection Receives: Biological: Recombinant erythropoietin injection (CHO cells)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of adverse events, adverse reactions and serious adverse events after single administration
Measured: Day1-Day29

Secondary outcomes (6)

Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum
Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures drug concentrations.
Measured: Day1-Day29
Concentration of recombinant human erythropoietin injection (Cho cell) in serum
Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures drug concentrations.
Measured: Day1-Day29
Erythrocyte count,before and after administration
Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures red blood cell counts.
Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures red blood cell counts.
Measured: Day1-Day29
hemoglobin,before and after administration
Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures hemoglobin concentrations.
Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures hemoglobin concentrations.
Measured: Day1-Day29
the percentage of erythrocyte red blood cells,before and after administration
Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures the percentage of erythrocyte red blood cells.
Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures the percentage of erythrocyte red blood cells.
Measured: Day1-Day29
erythrocyte ratio (HCT) before and after administration
Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures blood cell accumulations.
Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures blood cell accumulations.
Measured: Day1-Day29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 20189 Dec 2019

First posted26 Dec 2018
Study start3 Dec 2018
Primary completion3 Jul 2019
Study completion9 Dec 2019

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.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03786289
Sponsor's protocol ID: 1882-I
Status last verified: Oct 2020
First submitted: 16 Dec 2018
Last updated: 8 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage
ClinicalTrials.gov ID: NCT03786289
Acronym / sponsor ID: 1882-I
Conditions: Healthy Subjects
Keywords: Recombinant human erythropoietin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Tianjin SinoBiotech Ltd.Industry (pharma, biotech, devices)
Study start: 3 Dec 2018 (actual)
Primary completion: 3 Jul 2019 (actual)
Study completion: 9 Dec 2019 (actual)
First posted: 26 Dec 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Recombinant human serum albumin/erythropoietin fusion protein	Experimental	Biological: Recombinant human serum albumin/erythropoietin fusion proteinRecombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection
Recombinant human erythropoietin injection (CHO cells)	Active comparator	Biological: Recombinant erythropoietin injection (CHO cells)Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Body mass index (BMI) in the range of 19.0~26.0 (including critical value) (bmi= bw (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg
Understand and sign the informed consent form

Key exclusion criteria (19 listed)

Persons with allergic physique or sensitive skin;
Any person with any skin disease;
have a history of drug or food allergies, especially for the active ingredients of this product or similar drugs, mammalian cells to The source of the drug, human serum albumin or other biological agents expressed in CHO allergy;
Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;

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
Recombinant human serum albumin/erythropoietin fusion proteinRecombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1	Biological	Recombinant human serum albumin/erythropoietin fusion protein
Recombinant erythropoietin injection (CHO cells)Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1	Biological	Recombinant human erythropoietin injection (CHO cells)

Primary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Day1-Day29
Incidence of adverse events, adverse reactions and serious adverse events after single administration

6 secondary outcomes

Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum
Time frame: Day1-Day29
Concentration of recombinant human erythropoietin injection (Cho cell) in serum
Time frame: Day1-Day29
Erythrocyte count,before and after administration
Time frame: Day1-Day29
hemoglobin,before and after administration
Time frame: Day1-Day29
the percentage of erythrocyte red blood cells,before and after administration
Time frame: Day1-Day29
erythrocyte ratio (HCT) before and after administration
Time frame: Day1-Day29

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 Oct 2020.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 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 Oct 2020. 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?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Day1-Day29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03786289.

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 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.