Covid19Phase 1NCT04766931
The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection
A Phase 1 study testing FB2001 in people with Covid19, run by Frontier Biotechnologies Inc. at 1 site in United States.
Trial summary
This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- 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
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 12 Aug 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
- Subjects are required to meet ALL of the following criteria for enrollment into the Part 1 of the study:
- 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 which would adversely affect the study conduct and data interpretation per the investigator;
- Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission:
- Subjects of reproductive age and their partners agree to take 2 forms of effective contraceptive measures. Note: Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
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- Surgically sterile, with documentation, for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation, Bilateral salpingectomy (with or without oophorectomy), Surgical hysterectomy, Bilateral oophorectomy (with or without hysterectomy), Postmenopausal, defined as the following: Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening
- Agree to refrain from alcohol during the study;
- Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement including the 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;
- Subjects should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent;
- Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 12 weeks after completion of dosing with the study drug and must refrain from donating sperm for this same period;
- 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.
Who cannot join
- Subjects are required to meet NONE of the following criteria for enrollment into the Part 1 of the study:
- HIV antibody positive;
- HbsAg positive;
- HCV antibody positive;
- History of tuberculosis or lung disease as reported by subject;
- As reported by the subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung 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 interpretation
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- Female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion;
- Subjects who participated in any other clinical study within 30 days prior to screening;
- Subjects with known allergic reactions to the study drug or its excipients;
- Use of any medication, including prescription or over the counter, vitamins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects:
- Poor venous access or issues with needle sticks, e.g., syncope
- Donated or lost >500 mL of blood in the previous 3 months
- A history of prescription drug abuse, illicit drug use within 9 months prior to screening
- A positive screen for alcohol or drugs of abuse at screening or admission
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Two-part, Phase I/II, Multi-center, Double-Blind, Randomized, Vehicle-controlled Study of the Safety and Efficacy of FB2001 in Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19) Infection
This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease.
Read the detailed description
In Part 1 of this study, all subjects, after signing the Informed Consent Form (ICF), will be assessed during the screening phase. Only those subjects who successfully complete the screening phase and meet the study eligibility criteria will proceed to receive study treatment at the assigned doses and will be followed up for 14 days (for SAD) and 28 days (for MAD) to assess post-treatment safety.
- Conditions
- Covid19
- Being tested
- FB2001, FB2001 Placebo
- Keywords
- SARS-CoV-2
- 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 PlaceboDrug
Also called Placebo
Subjects will be administered with FB2001 placebo by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| A1 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A2 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A3 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A4 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A5 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A6 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A7 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| B1 FB2001 or Placebo | Experimental | Once daily for 5 days Receives: Drug: FB2001; Drug: FB2001 Placebo |
| B2 FB2001 or Placebo | Experimental | Once daily for 5 days Receives: Drug: FB2001; Drug: FB2001 Placebo |
| A8 FB2001 or Placebo | Experimental | single dose Receives: Drug: FB2001; Drug: FB2001 Placebo |
| B3 FB2001 or Placebo | Experimental | Twice daily for 5 days Receives: Drug: FB2001; Drug: FB2001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Tolerable Dose (MTD)
Determination of the Maximum Tolerable Dose (MTD) of FB2001 based on the occurrence of Dose Limiting Toxicities (DLTs).
Measured: 0~5 days
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy volunteers.
Measured: 0~28 days
Pharmacokinetic parameters(Cmax)
Estimate of steady state Cmax for multiple dose administration of FB2001.
Measured: 0~5 days
Pharmacokinetic parameters(AUC0-τ)
Estimate of steady state AUC0-τ for multiple dose administration of FB2001.
Measured: 0~5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start17 Mar 2021
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Yao, Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766931
- Sponsor's protocol ID
- FB2001-102
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Phase I/II, Multi-center, Double-Blind, Randomized, Vehicle-controlled Study of the Safety and Efficacy of FB2001 in Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT04766931
- Acronym / sponsor ID
- FB2001-102
- Conditions
- Covid19
- Keywords
- SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 23 Feb 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.
This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease.
Detailed description
In Part 1 of this study, all subjects, after signing the Informed Consent Form (ICF), will be assessed during the screening phase. Only those subjects who successfully complete the screening phase and meet the study eligibility criteria will proceed to receive study treatment at the assigned doses and will be followed up for 14 days (for SAD) and 28 days (for MAD) to assess post-treatment safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| A1 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| A2 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| A3 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| A4 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| A5 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| A6 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| A7 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| B1 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 PlaceboOnce daily for 5 days |
| B2 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 PlaceboOnce daily for 5 days |
| A8 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 Placebosingle dose |
| B3 FB2001 or Placebo | Experimental | Drug: FB2001, Drug: FB2001 PlaceboTwice daily for 5 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects are required to meet ALL of the following criteria for enrollment into the Part 1 of the study:
- 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 which would adversely affect the study conduct and data interpretation per the investigator;
- Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission:
Key exclusion criteria (15 listed)
- Subjects are required to meet NONE of the following criteria for enrollment into the Part 1 of the study:
- HIV antibody positive;
- HbsAg positive;
- HCV 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 | A1 FB2001 or Placebo, A2 FB2001 or Placebo, A3 FB2001 or Placebo, A4 FB2001 or Placebo, A5 FB2001 or Placebo, A6 FB2001 or Placebo, A7 FB2001 or Placebo, A8 FB2001 or Placebo, B1 FB2001 or Placebo, B2 FB2001 or Placebo, B3 FB2001 or Placebo |
| FB2001 PlaceboAlso: PlaceboSubjects will be administered with FB2001 placebo by intravenous (IV) infusion | Drug | A1 FB2001 or Placebo, A2 FB2001 or Placebo, A3 FB2001 or Placebo, A4 FB2001 or Placebo, A5 FB2001 or Placebo, A6 FB2001 or Placebo, A7 FB2001 or Placebo, A8 FB2001 or Placebo, B1 FB2001 or Placebo, B2 FB2001 or Placebo, B3 FB2001 or Placebo |
Primary outcome
The Maximum Tolerable Dose (MTD)
Time frame: 0~5 days
Determination of the Maximum Tolerable Dose (MTD) of FB2001 based on the occurrence of Dose Limiting Toxicities (DLTs).
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
Time frame: 0~28 days
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy volunteers.
Pharmacokinetic parameters(Cmax)
Time frame: 0~5 days
Estimate of steady state Cmax for multiple dose administration of FB2001.
Pharmacokinetic parameters(AUC0-τ)
Time frame: 0~5 days
Estimate of steady state AUC0-τ for 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 28 Nov 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.
Cheng Yao study director
Frontier Biotechnologies Inc.
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 Covid19, run by Frontier Biotechnologies Inc. at 1 site in United States.
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 15 inclusion and 15 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 28 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 United States. 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?
The Maximum Tolerable Dose (MTD) (time frame: 0~5 days). The study lists 4 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 28 Nov 2022.