TolerancePhase 1NCT04820049
F573 Ia Clinical Trial
A Phase 1 study testing F573 in people with Tolerance and Pharmacokinetic, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
Tolerance and PK study of F573 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerance, Pharmacokinetic
- What is being tested?
- F573
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2021to 6 Nov 2022
- 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 volunteers, male and female;
- Age: 18-45 years old;
- Weight: male ≥50kg, female ≥45kg, 19≤BMI≤26 (BMI= weight (kg)/height 2 (m2));
- Passed the comprehensive physical examination, that is, the routine blood and urine, blood pregnancy, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, electrocardiogram, cigarette test, urine drug screening, alcohol breath test, chest X-ray and other abnormal or abnormal without clinical significance;
- Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial before the study, and voluntarily participate in the clinical trial, be able to communicate well with the researchers, comply with the requirements of the whole study, and have the ability to understand and sign the written informed consent.
Who cannot join
- Participated in any other clinical trials within the three months prior to the trial;
- (preliminary) of any process may affect test security, or drug in the body of the disease, including but not limited to: heart, liver, kidney, endocrine, the digestive tract, immune system and respiratory system always or the existing system diseases (especially cardiovascular diseases including cardiovascular disease risk, any impact on drug absorption of gastrointestinal diseases (such as irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, eczema, dermatitis, epilepsy, allergic rhinitis, asthma, etc.);
- (Inquiry) Allergic constitution: if there is a history of drug, food allergy or skin allergy;
- (Inquiry) Use of any drug that inhibits or induces liver metabolism to the drug within 28 days prior to use of the study drug (Common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, griseofulvin, metalpropanol, phenytoin, glumide, rifampicin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
- Have used any medicine (including Chinese herbal medicine) and health care products within 14 days before the first administration;
- (Consultation) People who have special requirements for food and cannot abide by the unified diet (such as intolerance to standard food);
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- (consultation) can not tolerate venipuncture, intramuscular injection and/or have a history of dizziness of blood and needles;
- (Consultation) Drinking excessively tea, coffee or caffeinated beverages for a long time in the past (more than 8 cups a day, 1 cup =250mL); Or study within 48 hours before the first administration of the drug, the intake of any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) and other special diet that affects the absorption, distribution, metabolism, excretion of the drug;
- (Inquiry) Previous alcohol abuse (i.e., more than 28 SUs per week for men and more than 21 SUs per week for women (1 SU contains 14 g of alcohol, such as 360 mL beer or 45 mL 40% spirits or 150 mL wine); Or regular alcohol consumption (more than 14 standard units per week) in the 6 months prior to the study; Or have taken any alcoholic product within 24 hours prior to first administration;
- (Inquiry) who donated blood or suffered massive bleeding (greater than 450 mL) within 3 months before the first administration of the study, or who planned to donate blood or blood components during the study or within 3 months after the end of the study;
- (Inquiry) Acute disease occurs in the pre-study screening stage or before the study medication;
- (Inquiry) Those who took food or beverage (such as grapefruit, mango, dragon fruit, grape juice, orange juice and other rich flavonoids or citrus compounds) containing enzymes that can induce or inhibit liver metabolism within 24 hours before the first administration of medication;
- (Consultation) had surgery within 3 months prior to the screening period, or planned to have surgery during the study period;
- (Inquiry) Previous history of drug abuse; With a history of drug abuse;
- Smoking more than 5 cigarettes per day in the 14 days before screening, or unable to stop using any tobacco products during the trial;
- Screening (Consultation) Those who smoked or used any tobacco products during the admission period;
- Positive results of nicotine test;
- Alcohol breath test with test results greater than 0.0mg/100mL;
- Positive urine drug screening;
- Pregnant or lactating women;
- Those who had family planning during the study period and within 6 months after the end of the study;
- Refusing to use non-drug contraception during the study period
- novel coronavirus nucleic acid test positive or antibody test positive;
- The investigator considers that there is any circumstance that may affect the subject's ability to give informed consent or follow the study protocol, or that the participant's participation in the study may affect the study result or their own safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: F573 for Injection Phase Ia Clinical Trial.
Tolerance and PK study of F573
Read the detailed description
The tolerance and PK study of single dose and multi dose F573.
- Conditions
- Tolerance, Pharmacokinetic
- Being tested
- F573, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F573Drug
F573 for injection
PlaceboOther
Water for injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo |
| F573 group | Experimental | Not described Receives: Drug: F573 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of F573 in health people
Measured: up to 7 days
Cmax of F573 in health people
Measured: up to 7 days
Tmax of F573 in health people
Measured: up to 7 days
t1/2 of F573 in health people
Measured: up to 7 days
AUC of F573 in health people
Measured: up to 7 days
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start8 Feb 2021
- Primary completion2 Aug 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820049
- Sponsor's protocol ID
- GNI-F573-202001
- Status last verified
- Mar 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F573 for Injection Phase Ia Clinical Trial.
- ClinicalTrials.gov ID
- NCT04820049
- Acronym / sponsor ID
- GNI-F573-202001
- Conditions
- Tolerance, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 29 Mar 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.
Tolerance and PK study of F573
Detailed description
The tolerance and PK study of single dose and multi dose F573.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Placebo |
| F573 group | Experimental | Drug: F573 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers, male and female;
- Age: 18-45 years old;
- Weight: male ≥50kg, female ≥45kg, 19≤BMI≤26 (BMI= weight (kg)/height 2 (m2));
- Passed the comprehensive physical examination, that is, the routine blood and urine, blood pregnancy, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, electrocardiogram, cigarette test, urine drug screening, alcohol breath test, chest X-ray and other abnormal or abnormal without clinical significance;
- Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial before the study, and voluntarily participate in the clinical trial, be able to communicate well with the researchers, comply with the requirements of the whole study, and have the ability to understand and sign the written informed consent.
Key exclusion criteria (24 listed)
- Participated in any other clinical trials within the three months prior to the trial;
- (preliminary) of any process may affect test security, or drug in the body of the disease, including but not limited to: heart, liver, kidney, endocrine, the digestive tract, immune system and respiratory system always or the existing system diseases (especially cardiovascular diseases including cardiovascular disease risk, any impact on drug absorption of gastrointestinal diseases (such as irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, eczema, dermatitis, epilepsy, allergic rhinitis, asthma, etc.);
- (Inquiry) Allergic constitution: if there is a history of drug, food allergy or skin allergy;
- (Inquiry) Use of any drug that inhibits or induces liver metabolism to the drug within 28 days prior to use of the study drug (Common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, griseofulvin, metalpropanol, phenytoin, glumide, rifampicin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
- Have used any medicine (including Chinese herbal medicine) and health care products within 14 days before the first administration;
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 |
|---|---|---|
| F573F573 for injection | Drug | F573 group |
| PlaceboWater for injection | Other | Placebo group |
Primary outcome
MTD of F573 in health people
Time frame: up to 7 days
Cmax of F573 in health people
Time frame: up to 7 days
Tmax of F573 in health people
Time frame: up to 7 days
t1/2 of F573 in health people
Time frame: up to 7 days
AUC of F573 in health people
Time frame: up to 7 days
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 8 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 8 Nov 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.
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?
A Phase 1 study testing F573 in people with Tolerance and Pharmacokinetic, run by Beijing Continent 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 5 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 8 Nov 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. 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?
MTD of F573 in health people (time frame: up to 7 days). The study lists 5 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 8 Nov 2022.