COVID-19Phase 1NCT05197179
A Bridging Study of FB2001 in Healthy Subjects
A Phase 1 study testing FB2001 in people with COVID-19, run by Frontier Biotechnologies Inc. at 1 site in China.
Trial summary
In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- FB2001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2021to 2 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults who are between 18 and 60 years old inclusive
- Weigh at least 45kg, with a BMI of 19 to 30 kg/m2 inclusive
- No serious underlying disease
- Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement, including complete blood count, biochemistry, coagulation indices and urinalysis
- Subjects should have a normal (or abnormal but not clinically significant) ECG and chest X-ray at screening
- Current non-smokers and those who have not smoked within the last 6 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
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- Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at screening.
- Agree to have no parenting plan during the study period and for 3 months after administration, and be able to use highly effective contraceptive measures, such as:
- Complete abstinence (e.g. as the preferred lifestyle)
- Intrauterine device (IUD)
- Female barrier method: cervical or uterine cap with spermicidal agent
- Tubal sterilization
- Vasectomy for male subjects or partners
- Hormone-containing contraceptives
- Levonorgestrel implant
- Progesterone injection
- Oral contrceptives (combined or progesterone alone)
- Vaginal contraceptive ring
- Transdermal contraceptive patch
- Willing to cooperate and be able to participate in the study, comply with all requirements of the program, and sign informed consent. .
Who cannot join
- HIV antibody positive;
- HBsAg positive;
- HCV antibody positive;
- Syphilis spirochetes antibody positive;
- History of tuberculosis or lung disease as reported by subject;
- Subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretations;
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- Female subjects who are pregnant, lactating or have pregnancy plans and cannot contracept as required;
- Subjects who participated in any other clinical study within 3 months prior to screening;
- Subjects with known allergic reactions to the study drug or its excipients;
- Subjects donated or lost ≥ 400 mL 3 months prior to the administration of study drugs; or subjects donated (including aphersis donation) or lost ≥ 200 mL 1 month prior to the administration;
- Subjects who have taken any drug that inhibits or induces hepatic drug-metabolizing enzymes (e.g., inducers: barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors: antidepressants like selective serotonin reuptake inhibitor (SSRI), cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotic drugs, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration; or subjects who have taken any prescription, over-the-counter, and herbal medications other than those listed above within 14 days prior to administration;
- Alcoholics or regular drinkers within 3 months, i.e., those who comsume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of liquor with 40% ABV or 150 mL of wine), or those who have a positive result in breath alcohol test;
- Use of any medication, including prescription, over-the-counter, vitatmins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first administration, in the Investigator's judgment, which may influence study results or subjects' safety;
- Any other clinical condition that, in the inverstigator's judgement, would potentially compromise study compliance or the abilityti evaluate safety and efficacy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FB2001 in Healthy Subjects
In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing.
Read the detailed description
Coronaviruses belong to the genus of coronavirus of the family coronaviruses. The viruses of the coronavirus genus are positive-sense single-stranded RNA viruses with envelopes, which are approximately 80-160 nm in diameter. Their genetic material is the largest among all RNA viruses and can infect both humans and animals. Coronaviruses can cause respiratory, intestinal, hepatic, and nervous system diseases of different severities. A total of 7 coronaviruses have been found, in which HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 mainly lead to mild and self-limiting upper respiratory tract infections in infected humans, such as common cold; two new types of β-coronaviruses have emerged in the past 12 years, namely severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV), and these two viruses can cause severe human diseases.
In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This study is a randomized, double-blinded, placebo-controlled, ascending dose to evaluate the pharmacokinetics, safety and tolerability of FB2001 for injection afer a single and multiple dose administrations in healthy subjects. A total of 40 healthy subjects are planned to be enrolled. Each group will include 8 subjects.
- Conditions
- COVID-19
- Being tested
- FB2001, FB2001 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.
FB2001Drug
Also called DC402234
Subjects will be administered with FB2001 by intravenous (IV) infusion
FB2001 placeboOther
Subjects will be administered with FB2001 by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Single-dose A | Other | A single dose A of FB2001 or placebo will be administered by intravenous (IV) infusion Receives: Drug: FB2001; Other: FB2001 placebo |
| Single-dose B | Other | A single dose B of FB2001 or placebo will be administered by intravenous (IV) infusion Receives: Drug: FB2001; Other: FB2001 placebo |
| Multiple-dose A | Other | Dose A of FB2001 or placebo will be administered by intravenous (IV) infusion once daily for 5 consecutive days Receives: Drug: FB2001; Other: FB2001 placebo |
| Multiple-dose B | Other | Dose B of FB2001 or placebo will be administered by intravenous (IV) infusion twice daily for 5.5 consecutive days Receives: Drug: FB2001; Other: FB2001 placebo |
| Single-dose C | Other | A single dose C of FB2001 or placebo will be administered by intravenous (IV) infusion Receives: Drug: FB2001; Other: FB2001 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy subjects
The safety and overall tolerability assessments will be evaluated based on:
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Adverse reactions (ADR)
- Incidence of grade 3 and 4 AEs/ADRs
- Incidence of SAE
- Incidence of drug-related serious adverse events
Measured: Day1 - Day 29
Pharmacokinetic parameter (AUC0-τ)
Pharmacokinetic outcome measures: Estimate of steady state AUC0-τ for single and multiple dose administration of FB2001
Measured: Day1 - Day 6
Pharmacokinetic parameter (Cmax)
Pharmacokinetic outcome measures: Estimate of steady state Cmax for single and multiple dose administration of FB2001
Measured: Day1 - Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start29 Dec 2021
- Primary completion27 Apr 2022
- Study completion2 Jun 2022
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Liu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197179
- Sponsor's protocol ID
- FB2001-101
- Status last verified
- Jun 2022
- First submitted
- 16 Dec 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FB2001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05197179
- Acronym / sponsor ID
- FB2001-101
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 19 Jan 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.
In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing.
Detailed description
Coronaviruses belong to the genus of coronavirus of the family coronaviruses. The viruses of the coronavirus genus are positive-sense single-stranded RNA viruses with envelopes, which are approximately 80-160 nm in diameter. Their genetic material is the largest among all RNA viruses and can infect both humans and animals. Coronaviruses can cause respiratory, intestinal, hepatic, and nervous system diseases of different severities. A total of 7 coronaviruses have been found, in which HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 mainly lead to mild and self-limiting upper respiratory tract infections in infected humans, such as common cold; two new types of β-coronaviruses have emerged in the past 12 years, namely severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV), and these two viruses can cause severe human diseases.
In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This study is a randomized, double-blinded, placebo-controlled, ascending dose to evaluate the pharmacokinetics, safety and tolerability of FB2001 for injection afer a single and multiple dose administrations in healthy subjects. A total of 40 healthy subjects are planned to be enrolled. Each group will include 8 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single-dose A | Other | Drug: FB2001, Other: FB2001 placeboA single dose A of FB2001 or placebo will be administered by intravenous (IV) infusion |
| Single-dose B | Other | Drug: FB2001, Other: FB2001 placeboA single dose B of FB2001 or placebo will be administered by intravenous (IV) infusion |
| Multiple-dose A | Other | Drug: FB2001, Other: FB2001 placeboDose A of FB2001 or placebo will be administered by intravenous (IV) infusion once daily for 5 consecutive days |
| Multiple-dose B | Other | Drug: FB2001, Other: FB2001 placeboDose B of FB2001 or placebo will be administered by intravenous (IV) infusion twice daily for 5.5 consecutive days |
| Single-dose C | Other | Drug: FB2001, Other: FB2001 placeboA single dose C of FB2001 or placebo will be administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Male or female adults who are between 18 and 60 years old inclusive
- Weigh at least 45kg, with a BMI of 19 to 30 kg/m2 inclusive
- No serious underlying disease
- Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement, including complete blood count, biochemistry, coagulation indices and urinalysis
- Subjects should have a normal (or abnormal but not clinically significant) ECG and chest X-ray at screening
Key exclusion criteria (14 listed)
- HIV antibody positive;
- HBsAg positive;
- HCV antibody positive;
- Syphilis spirochetes antibody positive;
- History of tuberculosis or lung disease as reported by subject;
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 |
|---|---|---|
| FB2001Also: DC402234Subjects will be administered with FB2001 by intravenous (IV) infusion | Drug | Multiple-dose A, Multiple-dose B, Single-dose A, Single-dose B, Single-dose C |
| FB2001 placeboSubjects will be administered with FB2001 by intravenous (IV) infusion | Other | Multiple-dose A, Multiple-dose B, Single-dose A, Single-dose B, Single-dose C |
Primary outcome
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy subjects
Time frame: Day1 - Day 29
The safety and overall tolerability assessments will be evaluated based on: * Incidence of Treatment-Emergent Adverse Events (TEAEs) and Adverse reactions (ADR) * Incidence of grade 3 and 4 AEs/ADRs * Incidence of SAE * Incidence of drug-related serious adverse events
Pharmacokinetic parameter (AUC0-τ)
Time frame: Day1 - Day 6
Pharmacokinetic outcome measures: Estimate of steady state AUC0-τ for single and multiple dose administration of FB2001
Pharmacokinetic parameter (Cmax)
Time frame: Day1 - Day 6
Pharmacokinetic outcome measures: Estimate of steady state Cmax for single and multiple dose administration of FB2001
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 6 Jul 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.
Yun Liu principal investigator
Xuhui Central Hospital, Shanghai
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 FB2001 in people with COVID-19, run by Frontier Biotechnologies Inc. 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 20 inclusion and 14 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 6 Jul 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?
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy subjects (time frame: Day1 - Day 29). The study lists 3 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 6 Jul 2022.