COVID-19 PandemicPhase 1NCT05583812
A Study of FB2001 for Inhalation in Healthy Chinese Adults
A Phase 1 study testing FB2001 for inhalation in people with COVID-19 Pandemic, run by Frontier Biotechnologies Inc. at 1 site in China.
Trial summary
FB2001 is a novel inhalable preparation being developed for COVID-19 treatment. A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 in Healthy Chinese Adults 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 Pandemic
- What is being tested?
- FB2001 for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2022to 30 Dec 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
- Healthy Chinese male and female volunteers aged 18 to 60 years (including the threshold);
- Male weight ≥ 50 kg and female weight ≥ 45 kg with body mass index (BMI) = weight (kg)/height2 (m2) BMI within the range of 19 to 26 kg/m2 (including the threshold);
- Voluntary participation in the trial and full understanding of the trial content, process and possible adverse effects;
- 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
- Participation in any clinical trial within 3 months prior to the administration of the drug;
- Previous history of respiratory disease such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary oedema, interstitial lung lesions, bronchial asthma, paradoxical bronchospasm, or pharyngeal ulceration, oedema, or previous pharyngeal, tracheal/bronchial and pulmonary surgery which the investigator considers to be clinically significant;
- A history of cardiovascular, endocrine, neurological, digestive, genitourinary, haematological, immunological (including personal or family history of hereditary immunodeficiency), or metabolic abnormalities which the investigator considers to be clinically significant;
- Volunteers with a history of allergy to the product and excipients, or a history of hypersensitivity to drugs, foods or other substances;
- Volunteers with a history of intolerance to venipuncture or needle phobia and bloodsickness；
- Volunteers who have undergone surgery within 6 months prior to dosing which in the judgment of the investigator would interfere with the absorption, distribution, metabolism, or excretion, or who have undergone or are scheduled to undergo surgery during the study period within 4 weeks prior to dosing；
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- Volunteers having used any medication (including prescription, over-the-counter, herbal, nutraceuticals, etc.) within 14 days prior to administration of the experimental drug；
- volunteers having used any drug metabolism inhibitors or inducers within 30 days prior to the administration of the drug；
- Volunteers receiving a vaccine or attenuated vaccine within 14 days prior to dosing, or planning to have a vaccine administered during the trial；
- Volunteers having donated or lost blood (>400 mL) within 3 months prior to drug administration or intending to donate blood or blood components during or up to 3 months after the end of the trial；
- substance abusers or having used drugs within 1 year prior to dosing；
- smokers, or unable to stop using any tobacco-based products during the trial；
- alcoholics or regular drinkers of alcohol within 6 months prior to the administration；
- Volunteers consuming excessive amounts of tea, coffee and/or caffeinated beverages on a daily basis or requiring continued drinking during the trial；
- volunteers having ingested food within 7 days prior to administration that may interfere with the metabolism of the drug in vivo or will be unwilling to stop consuming these foods during the trial.
- Volunteers with special dietary requirements unable to comply with a uniform diet.
- volunteers (or their partners) planning to pregnant，donating sperm and oocytes or unwilling to use one or more non-pharmaceutical contraceptive measures within the period of the trial and up to 3 months after the trial ；
- Female volunteers are pregnant or lactating; or are having unprotected sex within 2 weeks prior to administration; or are using oral contraceptives within 30 days prior to the administration or using long-acting estrogen or progestin injections or implant tablets within 6 months prior to administration；
- volunteers with clinically significant abnormalities in physical examination, 12-lead ECG, vital signs (blood pressure, pulse, temperature, SpO2), chest X-ray, pregnancy tests, laboratory tests, pulmonary function tests；
- Pulmonary function tests: those with FEV1 measured/FEV1 expected ≤ 80% or FVC ≤ 80% of the expected value；
- Positive Niacin test result.
- Positive drug test result.
- positive alcohol breath test.
- inability to use the nebulizer device correctly or failure of training in inhalant administration.
- The volunteer may be unable to complete the study for other reasons or has other reasons judged by the investigator as inappropriate for participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 for Inhalation in Healthy Chinese Adults
FB2001 is a novel inhalable preparation being developed for COVID-19 treatment. A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 in Healthy Chinese Adults
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.
This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of FB2001 in healthy adult volunteers.The study aims to evaluate the safety, tolerability and pharmacokinetic profile of FB2001 administered by aerosol inhalation after single and multiple ascending doses.Approximately 32 participants will be sequentially enrolled into either 1 of 2 SAD cohorts (n=8 per cohort), or 1 of 2 MAD cohorts (n= 8 per cohort). An adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.
- Conditions
- COVID-19 Pandemic
- Being tested
- FB2001 for inhalation, FB2001 for inhalation 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.
FB2001 for inhalationDrug
Also called DC402234
FB2001 once or twice daily inhalation
FB2001 for inhalation placeboDrug
FB2001 placebo once or twice daily inhalation
| Study group | Role | What they receive |
|---|---|---|
| SAD Dose 1 | Experimental | Subjects will receive FB2001 or placebo for inhalation once on DAY 1 Receives: Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo |
| SAD Dose 2 | Experimental | Subjects will receive FB2001 or placebo for inhalation once on DAY 1 Receives: Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo |
| MAD Dose 1 | Experimental | Subjects will receive FB2001 or placebo for inhalation twice daily during the dosing period Receives: Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo |
| MAD Dose 2 | Experimental | Subjects will receive FB2001 or placebo for inhalation twice daily during the dosing period Receives: Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after single and multiple doses of FB2001 in healthy subjects
Assessment of safety by monitoring the incidence of AE after drug administration
Measured: Day 7 or Day 14
Pharmacokinetic parameter (AUC0-t)
Pharmacokinetic outcome measures: Estimate of steady state AUC0-t for single and multiple dose administration of FB2001 for Inhalation
Measured: Day 7 or Day 14
Pharmacokinetic parameter (Cmax)
Pharmacokinetic outcome measures: Estimate of steady state Cmax for single and multiple dose administration of FB2001 for Inhalation
Measured: Day 7 or Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start21 Oct 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Li, PhD, Principal investigator, Changsha Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583812
- Sponsor's protocol ID
- FB2001-103
- Status last verified
- Sep 2022
- First submitted
- 8 Oct 2022
- Last updated
- 11 Jan 2023
- 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 for Inhalation in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT05583812
- Acronym / sponsor ID
- FB2001-103
- Conditions
- COVID-19 Pandemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Oct 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.
FB2001 is a novel inhalable preparation being developed for COVID-19 treatment. A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 in Healthy Chinese Adults
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.
This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of FB2001 in healthy adult volunteers.The study aims to evaluate the safety, tolerability and pharmacokinetic profile of FB2001 administered by aerosol inhalation after single and multiple ascending doses.Approximately 32 participants will be sequentially enrolled into either 1 of 2 SAD cohorts (n=8 per cohort), or 1 of 2 MAD cohorts (n= 8 per cohort). An adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD Dose 1 | Experimental | Drug: FB2001 for inhalation, Drug: FB2001 for inhalation placeboSubjects will receive FB2001 or placebo for inhalation once on DAY 1 |
| SAD Dose 2 | Experimental | Drug: FB2001 for inhalation, Drug: FB2001 for inhalation placeboSubjects will receive FB2001 or placebo for inhalation once on DAY 1 |
| MAD Dose 1 | Experimental | Drug: FB2001 for inhalation, Drug: FB2001 for inhalation placeboSubjects will receive FB2001 or placebo for inhalation twice daily during the dosing period |
| MAD Dose 2 | Experimental | Drug: FB2001 for inhalation, Drug: FB2001 for inhalation placeboSubjects will receive FB2001 or placebo for inhalation twice daily during the dosing period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese male and female volunteers aged 18 to 60 years (including the threshold);
- Male weight ≥ 50 kg and female weight ≥ 45 kg with body mass index (BMI) = weight (kg)/height2 (m2) BMI within the range of 19 to 26 kg/m2 (including the threshold);
- Voluntary participation in the trial and full understanding of the trial content, process and possible adverse effects;
- Willing to cooperate and be able to participate in the study, comply with all requirements of the program, and sign informed consent.
Key exclusion criteria (25 listed)
- Participation in any clinical trial within 3 months prior to the administration of the drug;
- Previous history of respiratory disease such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary oedema, interstitial lung lesions, bronchial asthma, paradoxical bronchospasm, or pharyngeal ulceration, oedema, or previous pharyngeal, tracheal/bronchial and pulmonary surgery which the investigator considers to be clinically significant;
- A history of cardiovascular, endocrine, neurological, digestive, genitourinary, haematological, immunological (including personal or family history of hereditary immunodeficiency), or metabolic abnormalities which the investigator considers to be clinically significant;
- Volunteers with a history of allergy to the product and excipients, or a history of hypersensitivity to drugs, foods or other substances;
- Volunteers with a history of intolerance to venipuncture or needle phobia and bloodsickness；
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 |
|---|---|---|
| FB2001 for inhalationAlso: DC402234FB2001 once or twice daily inhalation | Drug | MAD Dose 1, MAD Dose 2, SAD Dose 1, SAD Dose 2 |
| FB2001 for inhalation placeboFB2001 placebo once or twice daily inhalation | Drug | MAD Dose 1, MAD Dose 2, SAD Dose 1, SAD Dose 2 |
Primary outcome
Safety and tolerability after single and multiple doses of FB2001 in healthy subjects
Time frame: Day 7 or Day 14
Assessment of safety by monitoring the incidence of AE after drug administration
Pharmacokinetic parameter (AUC0-t)
Time frame: Day 7 or Day 14
Pharmacokinetic outcome measures: Estimate of steady state AUC0-t for single and multiple dose administration of FB2001 for Inhalation
Pharmacokinetic parameter (Cmax)
Time frame: Day 7 or Day 14
Pharmacokinetic outcome measures: Estimate of steady state Cmax for single and multiple dose administration of FB2001 for Inhalation
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 11 Jan 2023.
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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.
Xin Li, PhD principal investigator
Changsha Third Hospital
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 for inhalation in people with COVID-19 Pandemic, 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 4 inclusion and 25 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 11 Jan 2023. 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?
Safety and tolerability after single and multiple doses of FB2001 in healthy subjects (time frame: Day 7 or Day 14). 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 11 Jan 2023.