COVID-19Phase 1NCT05483504
Clinical Study of F61 Injection in Healthy Chinese Subjects
A Phase 1 study testing F61 injection in people with COVID-19, run by Wuhan Institute of Biological Products Co., Ltd.
Trial summary
Main purpose： To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects. Secondary purpose： To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by single ascending intravenous infusion 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
- COVID-19
- What is being tested?
- F61 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Dec 2023
- 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
- Healthy subjects aged 18-45 years (including the cut-off value);
- The weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg, and the upper limit of acceptable weight is 80.0 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), with a BMI in the range of 18.0-28.0 kg/m2 (including critical values);
- Physical examination, vital signs, laboratory examinations and other auxiliary examinations (frontal and lateral chest X-ray, abdominal B-ultrasound, 12-lead electrocardiogram, etc.) are normal or have no clinical significance;
- Subjects (including partners) have no plans to become pregnant and voluntarily take effective contraceptive measures from the time of signing informed consent to the administration of the study drug within 6 months; The subjects can understand the research content and voluntarily sign the informed consent; at the same time, they can complete the research according to the requirements of the protocol.
Who cannot join
- Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, who have had contact with confirmed or suspected cases of new coronavirus within 14 days before signing the informed consent form, or who have traveled abroad in areas with high epidemic incidence; or who have been infected with new coronavirus or carrier;
- Patients with clinically significant abnormalities in the cardiovascular system, respiratory system, digestive system, endocrine system (diabetes), nervous/mental system, blood and lymphatic system (immune system deficiency), and skeletal muscle system confirmed by researchers ;
- Positive results of any of the combined detection of hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [Anti-HCV], human immunodeficiency virus [HIV] antigen and antibody, and Treponema pallidum specific antibody [TP-Ab];
- Those who are known to have a history of allergies to the test drugs or excipients, or have allergies;
- Those who have a history of vaccination within 3 months before screening, or those who have any vaccination plan during the clinical trial;
- Those who received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid therapy within 5 years before screening;
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- Have taken any over-the-counter, prescription, traditional Chinese medicine or vitamin within 1 month before screening;
- Those who plan to operate during the trial;
- Those who have a history of drug abuse or a positive urine drug screening test within 12 months before screening;
- Regular drinkers within 6 months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or who cannot be guaranteed to give up during the trial Alcoholic drinkers, or those with a positive breath test for alcohol;
- Those who smoked ≥5 cigarettes per day in the 3 months before screening or those who cannot guarantee to give up smoking during the trial;
- Those who have participated in clinical trials of other drugs within 3 months before screening (the last visit of the last trial is the start time);
- Those who donated blood or lost more than 450 mL of blood within 3 months before screening;
- Those who received ≥2 units of blood products within 3 months before screening;
- Those who use tobacco, alcohol or caffeinated beverages, or strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion within 24 hours before the test administration and during the test;
- Those who plan to participate in vigorous exercise during the test, including contact sports or collision sports;
- Women who are pregnant or breastfeeding, or those who have a positive pregnancy test result before the test; those who cannot take a medically approved non-drug contraceptive measure during the test according to the requirements of the investigator, or those who have Sperm/egg donation planners (from signing the informed consent form to within 6 months after the end of the trial);
- Difficulty in venous blood collection or fainting of needles; The investigators think that they are not suitable to participate in this clinical trial (such as infirmity, poor compliance, etc.).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Immunogenicity of F61 Injection After a Single Dose in Healthy Chinese Subjects
Main purpose： To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects.
Secondary purpose： To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by single ascending intravenous infusion in healthy subjects.
Read more
Research design： This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalating first-in-human Phase I trial to evaluate the tolerability, safety, and pharmacokinetics of F61 injection (F61) in healthy subjects Characteristics and Immunogenicity.
Test drug： F61 injection, specification: 150 mg/5ml/bottle, batch number: 202202002-1, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed.
Control drug： F61 placebo, specification: 5 ml/bottle, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed.
No statistical assumptions
- Conditions
- COVID-19
- Being tested
- F61 injection, F61 Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F61 injectionDrug
Colorless or slightly yellow liquid, may be slightly opalescent
F61 PlaceboDrug
Colorless or slightly yellow liquid, may be slightly opalescent
| Study group | Role | What they receive |
|---|---|---|
| F61 injection | Active comparator | F61 injection, specification: 150 mg/5ml/bottle, batch number: 202202002-1, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed. Receives: Drug: F61 injection |
| F61 placebo | Placebo comparator | F61 placebo, specification: 5 ml/bottle, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed. Receives: Drug: F61 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Descriptive statistics of the number of adverse events
Measured: 105 days
adverse reactions
Descriptive statistics of the number of adverse reactions
Measured: 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483504
- Sponsor's protocol ID
- F61-01
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Immunogenicity of F61 Injection After a Single Dose in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05483504
- Acronym / sponsor ID
- F61-01
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wuhan Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Aug 2022 (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.
Main purpose： To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects.
Secondary purpose： To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by single ascending intravenous infusion in healthy subjects.
Research design： This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalating first-in-human Phase I trial to evaluate the tolerability, safety, and pharmacokinetics of F61 injection (F61) in healthy subjects Characteristics and Immunogenicity.
Test drug： F61 injection, specification: 150 mg/5ml/bottle, batch number: 202202002-1, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed.
Control drug： F61 placebo, specification: 5 ml/bottle, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed.
No statistical assumptions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F61 injection | Active comparator | Drug: F61 injectionF61 injection, specification: 150 mg/5ml/bottle, batch number: 202202002-1, produced by Wuhan Institute of Biological Products Co., Ltd. Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed. |
| F61 placebo | Placebo comparator | Drug: F61 PlaceboF61 placebo, specification: 5 ml/bottle, produced by Wuhan Institute of Biological Products Co., Ltd. Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 18-45 years (including the cut-off value);
- The weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg, and the upper limit of acceptable weight is 80.0 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), with a BMI in the range of 18.0-28.0 kg/m2 (including critical values);
- Physical examination, vital signs, laboratory examinations and other auxiliary examinations (frontal and lateral chest X-ray, abdominal B-ultrasound, 12-lead electrocardiogram, etc.) are normal or have no clinical significance;
- Subjects (including partners) have no plans to become pregnant and voluntarily take effective contraceptive measures from the time of signing informed consent to the administration of the study drug within 6 months; The subjects can understand the research content and voluntarily sign the informed consent; at the same time, they can complete the research according to the requirements of the protocol.
Key exclusion criteria (18 listed)
- Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, who have had contact with confirmed or suspected cases of new coronavirus within 14 days before signing the informed consent form, or who have traveled abroad in areas with high epidemic incidence; or who have been infected with new coronavirus or carrier;
- Patients with clinically significant abnormalities in the cardiovascular system, respiratory system, digestive system, endocrine system (diabetes), nervous/mental system, blood and lymphatic system (immune system deficiency), and skeletal muscle system confirmed by researchers ;
- Positive results of any of the combined detection of hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [Anti-HCV], human immunodeficiency virus [HIV] antigen and antibody, and Treponema pallidum specific antibody [TP-Ab];
- Those who are known to have a history of allergies to the test drugs or excipients, or have allergies;
- Those who have a history of vaccination within 3 months before screening, or those who have any vaccination plan during the clinical trial;
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 |
|---|---|---|
| F61 injectionColorless or slightly yellow liquid, may be slightly opalescent | Drug | F61 injection |
| F61 PlaceboColorless or slightly yellow liquid, may be slightly opalescent | Drug | F61 placebo |
Primary outcome
adverse events
Time frame: 105 days
Descriptive statistics of the number of adverse events
adverse reactions
Time frame: 105 days
Descriptive statistics of the number of adverse reactions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F61 injection in people with COVID-19, run by Wuhan Institute of Biological Products Co., Ltd.
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ling gui chen, master (18343113983, chenguiling707@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 105 days). The study lists 2 primary outcomes in all. 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 2 Aug 2022.