AscitesPhase 1NCT04641364
Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.
A Phase 1 study testing recombinant human albumin injection and human albumin injection in people with Ascites, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ascites
- What is being tested?
- recombinant human albumin injection and human albumin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to 6 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1）Informed consent form signed; 2) To be able to complete the study; 3) Subjects (including partners) are willing to take contraceptive measures; 4) 18-55 years of age; 5) Male subjects are no less than 50 kg.Female subjects are no less than 45 kg. Body mass index is 18-28kg / m2; 6) Normal cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 50%; 7) Physical examination and vital signs are normal.
Who cannot join
- Cigarettes Smoking subjects.
- Allergic constitution (multiple drugs and food allergies);
- History of drug use and/or alcohol abuse;
- Blood donation or massive blood loss (> 450 mL) within three months before screening;
- Taking any drugs, prescription, over-the-counter, vitamin products or herbal medicine within 14 days before screening;
- Diet or exercise have changed recently;
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- Using study drugs within three months;
- Risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
- ECG abnormalities (QTc > 470ms for males, > 480ms for females);
- Female subjects are in lactation. Pregnancy test is positive;
- Other Clinical laboratory tests abnormalities;
- Viral screening test is positive, including HBV, HCV, HIV, and Treponema pallidum;
- Developing Acute disease;
- Eating chocolate, any caffeine-containing or jaundice-rich food or drink 24 hours prior to the use of the study drug;
- Taking any alcoholic products. Alcohol test is positive..
- Drug test is positive. History of drug abuse or drug use in the past five years;
- Inability for intravenous injection or blood collection;
- Using biological products (including live vaccines) within the last 3 months. Planing to use vaccines during the study period. Having received corticosteroid or human plasma product system treatment within 1 month.
- Renal function is abnormal, glomerular filtration rate <80 mL/min (according to the simplified MDRD formula);
- History of glaucoma, eye disease.
- History of cancer or other serious systemic diseases, especially heart, liver, kidney, digestive tract, nervous system, metabolic abnormalities, immune abnormalities or mental disorders;
- History of immunodeficiency or hypofunction;
- Received major surgery within 2 years.
- Other subjects by investigator opinion..
Trial locations and contacts
1 site in 1 country.
About this study
A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects
Read the detailed description
This study was to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy volunteers. The safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection were evaluated in a single center, randomized, double-blind, placebo-controlled single dose incremental trial in healthy volunteers. The study was divided into two stages: the first stage was a single dose and dose increasing stage (including 5 dose groups with increasing dose, and each group was set with placebo control); the second stage was multiple administration stage (with positive control). The safety, tolerance, pharmacokinetics, immunogenicity and other early clinical data of recombinant human albumin were collected and analyzed in the two stages. The initial dose was 1.25g. The highest dose group was set at 30g. The dose groups of 1.25, 5, 10, 20 and 30 g / time were preset in the single dose stage (dose increasing stage). The dosage was 10 g / Day in multiple administration stage.
- Conditions
- Ascites
- Being tested
- recombinant human albumin injection, Placebo, human albumin injection
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human albumin injectionDrug
Also called Intravenous infusion of recombinant human albumin injection
single dose or multiple doses of intravenous infusion
PlaceboDrug
Also called Intravenous infusion of 0.9% sodium chloride injection
Single dose intravenous infusion of 0.9% sodium chloride injection
human albumin injectionDrug
Also called Intravenous infusion of human albumin injection
multiple doses of intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Control: placebo | Placebo comparator | Subjects received 0.9% sodium chloride injection. Receives: Drug: Placebo |
| Control: Human Serum Albumin(HSA) | Active comparator | Subjects received Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles. Receives: Drug: human albumin injection |
| Experimental:recombinant human albumin | Experimental | Subjects received recombinant Human Serum Albumin, 1.25g, 5g, 10g, 20g, 30 g for the single dose study. For the multiple dose study, subjects received recombinant Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles. Receives: Drug: recombinant human albumin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance
AE
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Secondary outcomes (6)
PK parameters
Maximum Plasma Concentration（Cmax）
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
PK parameters
time to Maximum Plasma Concentration（Tmax）
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
PK parameters
half life (t1/2）
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Pharmacodynamic parameters
Red blood cell specific volume
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Pharmacodynamic parameters
Plasma colloid osmotic pressure
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Immunogenicity
Percentage of patients with positive reaction
Measured: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start24 Jun 2019
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Dr, Study director, The first affiliated hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641364
- Sponsor's protocol ID
- ART-2019-001
- Status last verified
- Sep 2020
- First submitted
- 12 Oct 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT04641364
- Acronym / sponsor ID
- ART-2019-001
- Conditions
- Ascites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 23 Nov 2020 (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.
A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects
Detailed description
This study was to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy volunteers. The safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection were evaluated in a single center, randomized, double-blind, placebo-controlled single dose incremental trial in healthy volunteers. The study was divided into two stages: the first stage was a single dose and dose increasing stage (including 5 dose groups with increasing dose, and each group was set with placebo control); the second stage was multiple administration stage (with positive control). The safety, tolerance, pharmacokinetics, immunogenicity and other early clinical data of recombinant human albumin were collected and analyzed in the two stages. The initial dose was 1.25g. The highest dose group was set at 30g. The dose groups of 1.25, 5, 10, 20 and 30 g / time were preset in the single dose stage (dose increasing stage). The dosage was 10 g / Day in multiple administration stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control: placebo | Placebo comparator | Drug: PlaceboSubjects received 0.9% sodium chloride injection. |
| Control: Human Serum Albumin(HSA) | Active comparator | Drug: human albumin injectionSubjects received Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles. |
| Experimental:recombinant human albumin | Experimental | Drug: recombinant human albumin injectionSubjects received recombinant Human Serum Albumin, 1.25g, 5g, 10g, 20g, 30 g for the single dose study. For the multiple dose study, subjects received recombinant Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1）Informed consent form signed; 2) To be able to complete the study; 3) Subjects (including partners) are willing to take contraceptive measures; 4) 18-55 years of age; 5) Male subjects are no less than 50 kg.Female subjects are no less than 45 kg. Body mass index is 18-28kg / m2; 6) Normal cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 50%; 7) Physical examination and vital signs are normal.
Key exclusion criteria (24 listed)
- Cigarettes Smoking subjects.
- Allergic constitution (multiple drugs and food allergies);
- History of drug use and/or alcohol abuse;
- Blood donation or massive blood loss (> 450 mL) within three months before screening;
- Taking any drugs, prescription, over-the-counter, vitamin products or herbal medicine within 14 days before 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 |
|---|---|---|
| recombinant human albumin injectionAlso: Intravenous infusion of recombinant human albumin injectionsingle dose or multiple doses of intravenous infusion | Drug | Experimental:recombinant human albumin |
| PlaceboAlso: Intravenous infusion of 0.9% sodium chloride injectionSingle dose intravenous infusion of 0.9% sodium chloride injection | Drug | Control: placebo |
| human albumin injectionAlso: Intravenous infusion of human albumin injectionmultiple doses of intravenous infusion | Drug | Control: Human Serum Albumin(HSA) |
Primary outcome
Safety and tolerance
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
AE
6 secondary outcomes
PK parameters
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
PK parameters
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
PK parameters
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Pharmacodynamic parameters
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Pharmacodynamic parameters
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
Immunogenicity
Time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
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 23 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Junqi Niu, Dr study director
The first affiliated hospital of Jilin University
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 recombinant human albumin injection and human albumin injection in people with Ascites, run by The First Hospital of Jilin University 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 1 inclusion and 24 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 23 Nov 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. Some participants in this study may receive a placebo. 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?
Safety and tolerance (time frame: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.). 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 23 Nov 2020.