HealthyPhase 1NCT04851444
A Study of SI-F019 in Healthy Participants
A Phase 1 study testing SI-F019 in people with Healthy, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability and pharmacokinetic properties of a single intravenous administration of SI-F019 recombinant human bivalent ACE2-Fc fusion protein injection in healthy participants, and provide a basis for the design of subsequent clinical trials. 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?
- SI-F019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2021to 20 Sep 2021
- 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
- The participants fully understand the purpose, character, methods and possible adverse events of the trial, and volunteer to be the subject, and sign the informed consent form before the start of any study procedure, and guarantee that any procedure will be participated in the study by the participants themselves;
- The participant could communicate well with the investigator, and understand and comply with the requirements of this study.
- The participant has no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, breathing, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system, and is in good general health;
- The participants (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and within the next 6 months, and no sperm or egg donation plan, in which non-drug contraceptive measures should be used voluntarily during the trial period;
- Male or female subjects aged 18 to 45 (including 18 and 45 years old);
- Male weight ≥50.0 kg, female weight ≥45.0 kg; body mass index (BMI) is in the range of 19.0~26.0 kg/m2 (including cut-off value);
- Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood transfusion, blood coagulation function, pregnancy test (female), alcohol and drug screening, etc.), 12-lead electrocardiogram and Abdominal B-ultrasound examination showed no abnormalities or abnormalities without clinical significance.
Who cannot join
- Health condition: clinically significant medical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymph system, immune system, mental and metabolic abnormalities, and bones;
- Those who have a history of allergies to biological agents or any drug component; those who have a history of allergies and are judged not to be included in the group by the investigator;
- Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion;
- Those who cannot tolerate venipuncture or have a history of fainting needles and bleeding;
- Those who have a history of drug abuse within 6 months before screening;
- Used drugs within 3 months before screening;
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- Those who donated blood including blood components or a large amount of blood loss (≥200mL) within 3 months before screening, received blood transfusion or used blood products;
- The participant (female) is in pregnancy or lactation during the screening period or the test process;
- The participant has a birth plan or sperm donation or egg donation plan during the screening period and the next 6 months;
- Those who have used any prescription drugs, over-the-counter drugs, and Chinese herbal medicines within 2 weeks before screening;
- Those who have received vaccination within 4 weeks before screening, or plan to receive vaccination during the study period;
- Those who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the trial period;
- Drinking more than 14 units per week in the 3 months before screening (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or those who cannot abstain from alcohol during the test;
- Those who have special requirements for diet and cannot accept a unified diet;
- Those who have participated in drug clinical trials and used trial drugs within 3 months before screening;
- Received immunosuppressive agents or monoclonal antibodies before screening;
- For patients with abnormal vital signs that have clinical significance, refer to the normal range (including cut-off values): sitting systolic blood pressure 90~139mmHg, diastolic blood pressure 60~89mmHg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4~37.7℃, breathing 16-20 times/min, the specific situation will be judged comprehensively by the investigator;
- Any abnormality in laboratory examinations and auxiliary examinations, and the investigator judges that it has clinical significance;
- One or more of hepatitis B virological indicators, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody test has one or more clinical significance;
- Female participants who have a positive urine or blood pregnancy test result during the screening period;
- Alcohol breath test results greater than 0.0mg/100mL or drug screening positive (morphine, methamphetamine, ketamine, ecstasy (dimethyldioxyamphetamine), cannabis (tetrahydrocannabinolic acid);
- Acute illness occurred during the period from screening to -1 day of admission;
- Those who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines during the period from screening to -1 day of admission;
- The investigator determines that the participant is not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center Ethics Committee Approval Letter
Shanghai, Shanghai Municipality, 201508
About this study
Official title: A Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics of SI-F019 Recombinant Human Bivalent ACE2-Fc Fusion Protein Injection in a Single Dose in Healthy Subjects
To evaluate the safety, tolerability and pharmacokinetic properties of a single intravenous administration of SI-F019 recombinant human bivalent ACE2-Fc fusion protein injection in healthy participants, and provide a basis for the design of subsequent clinical trials.
- Conditions
- Healthy
- Being tested
- SI-F019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-F019Drug
Single dose is administered IV.
| Study group | Role | What they receive |
|---|---|---|
| SI-F019 | Experimental | SI-F019 administered intravenously (IV). Receives: Drug: SI-F019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE
Number of Adverse Events and Seriuos Adverse Events
Measured: Up to 29 days after the first dose of SI-F019
Secondary outcomes (2)
Tmax
Maximum Time
Measured: 7 days
t1/2
half time
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start30 Mar 2021
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
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.
- More trials run by Sichuan Baili Pharmaceutical 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Responsible party
- Sponsor
- Investigators
- Hongzhou Lu, Principal investigator, Shanghai Public Health Clinical Center Ethics Committee Approval Letter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851444
- Sponsor's protocol ID
- SI-F019-101
- Status last verified
- Dec 2022
- First submitted
- 12 Apr 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics of SI-F019 Recombinant Human Bivalent ACE2-Fc Fusion Protein Injection in a Single Dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04851444
- Acronym / sponsor ID
- SI-F019-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 20 Apr 2021 (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.
To evaluate the safety, tolerability and pharmacokinetic properties of a single intravenous administration of SI-F019 recombinant human bivalent ACE2-Fc fusion protein injection in healthy participants, and provide a basis for the design of subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SI-F019 | Experimental | Drug: SI-F019SI-F019 administered intravenously (IV). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The participants fully understand the purpose, character, methods and possible adverse events of the trial, and volunteer to be the subject, and sign the informed consent form before the start of any study procedure, and guarantee that any procedure will be participated in the study by the participants themselves;
- The participant could communicate well with the investigator, and understand and comply with the requirements of this study.
- The participant has no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, breathing, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system, and is in good general health;
- The participants (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and within the next 6 months, and no sperm or egg donation plan, in which non-drug contraceptive measures should be used voluntarily during the trial period;
- Male or female subjects aged 18 to 45 (including 18 and 45 years old);
Key exclusion criteria (24 listed)
- Health condition: clinically significant medical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymph system, immune system, mental and metabolic abnormalities, and bones;
- Those who have a history of allergies to biological agents or any drug component; those who have a history of allergies and are judged not to be included in the group by the investigator;
- Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion;
- Those who cannot tolerate venipuncture or have a history of fainting needles and bleeding;
- Those who have a history of drug abuse within 6 months 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 |
|---|---|---|
| SI-F019Single dose is administered IV. | Drug | SI-F019 |
Primary outcome
SAE
Time frame: Up to 29 days after the first dose of SI-F019
Number of Adverse Events and Seriuos Adverse Events
2 secondary outcomes
Tmax
Time frame: 7 days
t1/2
Time frame: 7 days
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 13 Dec 2022.
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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.
Hongzhou Lu principal investigator
Shanghai Public Health Clinical Center Ethics Committee Approval Letter
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 SI-F019 in people with Healthy, run by Sichuan Baili Pharmaceutical 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 7 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 13 Dec 2022. 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?
SAE (time frame: Up to 29 days after the first dose of SI-F019). 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 13 Dec 2022.