HealthyNCT05813041
A First-in-human Trial to Assess the Safety and Performance of the BioCaptis in Healthy Volunteers
A study testing BioCaptis in people with Healthy, run by BioCaptiva Ltd..
Trial summary
Liquid biopsy is a new field in medicine where doctors can look at small molecules in our blood, called DNA, that carry the genetic material that makes us who we are. In some illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified by looking closely at changes in a person's DNA. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BioCaptis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2023to 30 Sep 2023
- Phase
- Interventional
- 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
- Subject is willing and able to give informed consent for participation in the study
- All genders aged 18-60 years (inclusive)
- Healthy volunteer study therefore subjects must be deemed to be in good health by the Investigator
- Subject has acceptable clinical history at point of enrolment
- Subject has clinically acceptable laboratory and ECG assessments at point of enrolment
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow their General Practitioner (and all other relevant healthcare providers as appropriate) to be notified of participation in the study
- Adequate bilateral peripheral venous access (antecubital fossae, forearms) for apheresis catheter placement.
Who cannot join
- Subjects who are pregnant, lactating or planning pregnancy during the study
- Significant renal or hepatic impairment, or any disorder of blood cells or of blood coagulation
- Scheduled elective surgery, or other procedures requiring general anaesthesia, during the subject's time enrolled in the study
- Any significant disease or disorder, or any regular drug treatments which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study
- Donation of blood within the 12 weeks prior to enrolment
- Donation of platelets within the 3 weeks prior to enrolment
- Subjects who have participated in another research study involving an investigational product in the past 12 weeks.
About this study
Official title: A Single-site, First-in-human Trial to Assess the Safety and Performance of a Novel Device, the BioCaptis, for Capturing Cell-free DNA (cfDNA) in Healthy Human Subjects When Used in an Apheresis Circuit
Liquid biopsy is a new field in medicine where doctors can look at small molecules in our blood, called DNA, that carry the genetic material that makes us who we are. In some illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified by looking closely at changes in a person's DNA.
The BioCaptis is a new medical device which can capture molecules of DNA, called cell-free DNA, from a person's blood when used in a clinical procedure called apheresis. The purpose of the BioCaptis-1 clinical trial is to confirm that the BioCaptis is suitable for use in healthy volunteers. The main questions the study aims to answer are:
Read more
- Is the BioCaptis safe to use in healthy volunteers?
- Can the BioCaptis capture cell-free DNA from human plasma when used in an apheresis procedure?
Following completion of the informed consent process, participants in the study will complete six appointments over the course of the trial. Three of these will be telephone appointments, and three will be in-person visits at the clinical site. The three in-person visits will include:
- Screening Visit where screening tests will be performed to deem the participant suitable for enrollment;
- Procedural Visit during which the participant will undergo the apheresis procedure with the BioCaptis device;
- Post-procedure Follow Up Visit to check the particpant's health following the apheresis procedure.
Read the detailed description
Personalised medicine is a medical model which has developed rapidly in recent years, and it involves tailoring treatment plans to individual patients based on the type of disease they have and how they are expected to respond to certain treatment types. To develop personalised treatment plans for cancer patients, doctors look at a piece of tumour tissue taken from the patient which is called a biopsy. Doctors will examine this biopsy to identify genetic abnormalities which help to explain the behaviour of that tumour or indicate how that tumour could respond to certain anti-cancer treatments. This is called "molecular profiling."
Although tissue biopsy is widely used for molecular profiling, it has some drawbacks. Firstly, tissue biopsy is a highly invasive procedure which can cause stress to patients. Secondly, some biopsies are performed using a small needle, and due to the small size of this needle the tumour tissue can be missed meaning that there is no tumour tissue present in the sample to carry out necessary tests. Thirdly, tissue biopsy can't be used for real-time monitoring of cancers because multiple biopsies would be required from a patient over the course of their treatment which would cause additional stress and discomfort to them. So, an alternative biopsy method is needed to address these limitations.
A new field in medicine called "liquid biopsy" is becoming very popular. This is where a doctor can use a blood sample to diagnose an illness instead of having to take a tissue biopsy. Liquid biopsy works by looking at very small molecules in our blood, called DNA, that carry the genetic material that makes us who we are. In some illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified by looking closely at a person's DNA. One illness that liquid biopsy has the potential to identify is cancer because DNA from all the body's cells, including cancer cells, can be found in the blood stream. Doctors can then use this information to choose a treatment plan for the patient. Although it shows promise for use in molecular profiling, development of liquid biopsy has been held back because the amount of DNA that can be collected using a regular blood draw (the kind used in a doctor's surgery) is very low and does not give reliable results when used in laboratory tests. To address this limitation, BIOCAPTIVA has developed a medical device called the BioCaptis which is a small tube that has a special filter in it. The filter can capture up to 100 times more cfDNA than a regular blood sample when it is used during an apheresis procedure.
An apheresis procedure is a routine and safe process used to treat patients with a range of conditions. It is also used to collect blood cells from healthy donors that can then be used to treat sick patients. It works by connecting a patient or healthy donor to a machine. Blood flows from the person into the machine where it is then separated out into its main parts. The part of the blood that is causing the patient's condition, or contains the cells that can be used to treat patients, is removed and everything else is returned back to the person. Apheresis is a well-tolerated procedure, but as with all procedures there is some risk. The most commonly observed side effects are listed below:
- Bruising can occur at the needle puncture site.
- Sometimes the blood vessel that the needle has been placed in goes into spasm, so the blood flow slows down.
- A blood thinner is added into the machine to stop the person's blood from clotting while it is outside of their system. Some of it flows back into their system with the blood being returned which can cause tingling around the mouth or fingertips, or cause shivering.
The BioCaptis-1 study has been designed to confirm that the BioCaptis device is both safe to use and able to capture DNA from the blood of human subjects when used with an apheresis procedure. In this clinical trial, we will use an apheresis machine in combination with the BioCaptis device. The participant's plasma will pass through the BioCaptis and the filter inside the device will capture the DNA in the participant's plasma. Their plasma will then be combined with the rest of their blood and be returned to them.
As this is a completely new device, no similar research on this topic has been done before.
- Conditions
- Healthy
- Being tested
- BioCaptis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCaptisDevice
The BioCaptis is a medical device intended to capture cell-free DNA from peripheral blood for use in liquid biopsy. When used as a cartridge filter during an apheresis procedure in which plasma is passed through the device, the BioCaptis binds cfDNA which can be eluted, concentrated, and used as an input for cancer diagnostic tests.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Single arm trial - healthy volunteers will all undergo an apheresis procedure using the BioCaptis device. No comparator will be used for this trial. Receives: Device: BioCaptis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adverse events profile observed for all participants undergoing the investigational procedure to evaluate the safety of the BioCaptis device.
To assess the safety of the BioCaptis device as a binding column in an apheresis circuit in healthy human subjects. The outcome measure will be the adverse event profile (i.e. adverse device effects and serious adverse device effects) observed for healthy human subjects undergoing an apheresis procedure using the BioCaptis device.
Measured: Up to 7 days post-procedure
The amount of cfDNA (nanograms) that can be eluted and concentrated from the BioCaptis device after use to evaluate the performance of the device.
To confirm that the BioCaptis device can capture cfDNA, when used in an apheresis circuit. The outcome measure will be the amount of cfDNA (nanograms) that can be eluted and concentrated from the BioCaptis device after use of the device in an apheresis procedure.
Measured: Immediately after the procedure
Secondary outcomes (3)
For each subject, measure the amount of cfDNA collected using the BioCaptis device and compare it with the amount of cfDNA obtained from a paired 10mL blood draw in healthy human subjects
The amount of cfDNA obtained using the BioCaptis and from a paired 10mL blood draw.
Measured: Immediately after the procedure
For each subject, assess the fragment size profile of cfDNA collected using the BioCaptis and compare it with cfDNA obtained from a paired 10mL blood draw.
The fragment size distribution of cfDNA obtained using the BioCaptis and from a paired 10mL blood draw.
Measured: Immediately after the procedure
For each subject, assess the performance in molecular genetic assays, such as qPCR, of cfDNA obtained using the BioCaptis device and compare it with the performance of cfDNA obtained from a paired 10mL blood draw.
The amplification efficiency in a qPCR assay of cfDNA captured using the BioCaptis device and from a paired 10mL blood draw.
Measured: Up to 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start31 Jul 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical investigation of the safety and performance of a medical device. Single site, single arm, open label, healthy volunteer.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioCaptiva Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813041
- Sponsor's protocol ID
- BioCaptis-1
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, First-in-human Trial to Assess the Safety and Performance of a Novel Device, the BioCaptis, for Capturing Cell-free DNA (cfDNA) in Healthy Human Subjects When Used in an Apheresis Circuit
- ClinicalTrials.gov ID
- NCT05813041
- Acronym / sponsor ID
- BioCaptis-1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- BioCaptiva Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
Liquid biopsy is a new field in medicine where doctors can look at small molecules in our blood, called DNA, that carry the genetic material that makes us who we are. In some illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified by looking closely at changes in a person's DNA.
The BioCaptis is a new medical device which can capture molecules of DNA, called cell-free DNA, from a person's blood when used in a clinical procedure called apheresis. The purpose of the BioCaptis-1 clinical trial is to confirm that the BioCaptis is suitable for use in healthy volunteers. The main questions the study aims to answer are:
- Is the BioCaptis safe to use in healthy volunteers?
- Can the BioCaptis capture cell-free DNA from human plasma when used in an apheresis procedure?
Following completion of the informed consent process, participants in the study will complete six appointments over the course of the trial. Three of these will be telephone appointments, and three will be in-person visits at the clinical site. The three in-person visits will include:
- Screening Visit where screening tests will be performed to deem the participant suitable for enrollment;
- Procedural Visit during which the participant will undergo the apheresis procedure with the BioCaptis device;
- Post-procedure Follow Up Visit to check the particpant's health following the apheresis procedure.
Detailed description
Personalised medicine is a medical model which has developed rapidly in recent years, and it involves tailoring treatment plans to individual patients based on the type of disease they have and how they are expected to respond to certain treatment types. To develop personalised treatment plans for cancer patients, doctors look at a piece of tumour tissue taken from the patient which is called a biopsy. Doctors will examine this biopsy to identify genetic abnormalities which help to explain the behaviour of that tumour or indicate how that tumour could respond to certain anti-cancer treatments. This is called "molecular profiling."
Although tissue biopsy is widely used for molecular profiling, it has some drawbacks. Firstly, tissue biopsy is a highly invasive procedure which can cause stress to patients. Secondly, some biopsies are performed using a small needle, and due to the small size of this needle the tumour tissue can be missed meaning that there is no tumour tissue present in the sample to carry out necessary tests. Thirdly, tissue biopsy can't be used for real-time monitoring of cancers because multiple biopsies would be required from a patient over the course of their treatment which would cause additional stress and discomfort to them. So, an alternative biopsy method is needed to address these limitations.
A new field in medicine called "liquid biopsy" is becoming very popular. This is where a doctor can use a blood sample to diagnose an illness instead of having to take a tissue biopsy. Liquid biopsy works by looking at very small molecules in our blood, called DNA, that carry the genetic material that makes us who we are. In some illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified by looking closely at a person's DNA. One illness that liquid biopsy has the potential to identify is cancer because DNA from all the body's cells, including cancer cells, can be found in the blood stream. Doctors can then use this information to choose a treatment plan for the patient. Although it shows promise for use in molecular profiling, development of liquid biopsy has been held back because the amount of DNA that can be collected using a regular blood draw (the kind used in a doctor's surgery) is very low and does not give reliable results when used in laboratory tests. To address this limitation, BIOCAPTIVA has developed a medical device called the BioCaptis which is a small tube that has a special filter in it. The filter can capture up to 100 times more cfDNA than a regular blood sample when it is used during an apheresis procedure.
An apheresis procedure is a routine and safe process used to treat patients with a range of conditions. It is also used to collect blood cells from healthy donors that can then be used to treat sick patients. It works by connecting a patient or healthy donor to a machine. Blood flows from the person into the machine where it is then separated out into its main parts. The part of the blood that is causing the patient's condition, or contains the cells that can be used to treat patients, is removed and everything else is returned back to the person. Apheresis is a well-tolerated procedure, but as with all procedures there is some risk. The most commonly observed side effects are listed below:
- Bruising can occur at the needle puncture site.
- Sometimes the blood vessel that the needle has been placed in goes into spasm, so the blood flow slows down.
- A blood thinner is added into the machine to stop the person's blood from clotting while it is outside of their system. Some of it flows back into their system with the blood being returned which can cause tingling around the mouth or fingertips, or cause shivering.
The BioCaptis-1 study has been designed to confirm that the BioCaptis device is both safe to use and able to capture DNA from the blood of human subjects when used with an apheresis procedure. In this clinical trial, we will use an apheresis machine in combination with the BioCaptis device. The participant's plasma will pass through the BioCaptis and the filter inside the device will capture the DNA in the participant's plasma. Their plasma will then be combined with the rest of their blood and be returned to them.
As this is a completely new device, no similar research on this topic has been done before.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical investigation of the safety and performance of a medical device. Single site, single arm, open label, healthy volunteer.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: BioCaptisSingle arm trial - healthy volunteers will all undergo an apheresis procedure using the BioCaptis device. No comparator will be used for this trial. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is willing and able to give informed consent for participation in the study
- All genders aged 18-60 years (inclusive)
- Healthy volunteer study therefore subjects must be deemed to be in good health by the Investigator
- Subject has acceptable clinical history at point of enrolment
- Subject has clinically acceptable laboratory and ECG assessments at point of enrolment
Key exclusion criteria (7 listed)
- Subjects who are pregnant, lactating or planning pregnancy during the study
- Significant renal or hepatic impairment, or any disorder of blood cells or of blood coagulation
- Scheduled elective surgery, or other procedures requiring general anaesthesia, during the subject's time enrolled in the study
- Any significant disease or disorder, or any regular drug treatments which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study
- Donation of blood within the 12 weeks prior to enrolment
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 |
|---|---|---|
| BioCaptisThe BioCaptis is a medical device intended to capture cell-free DNA from peripheral blood for use in liquid biopsy. When used as a cartridge filter during an apheresis procedure in which plasma is passed through the device, the BioCaptis binds cfDNA which can be eluted, concentrated, and used as an input for cancer diagnostic tests. | Device | Investigational Device |
Primary outcome
The adverse events profile observed for all participants undergoing the investigational procedure to evaluate the safety of the BioCaptis device.
Time frame: Up to 7 days post-procedure
To assess the safety of the BioCaptis device as a binding column in an apheresis circuit in healthy human subjects. The outcome measure will be the adverse event profile (i.e. adverse device effects and serious adverse device effects) observed for healthy human subjects undergoing an apheresis procedure using the BioCaptis device.
The amount of cfDNA (nanograms) that can be eluted and concentrated from the BioCaptis device after use to evaluate the performance of the device.
Time frame: Immediately after the procedure
To confirm that the BioCaptis device can capture cfDNA, when used in an apheresis circuit. The outcome measure will be the amount of cfDNA (nanograms) that can be eluted and concentrated from the BioCaptis device after use of the device in an apheresis procedure.
3 secondary outcomes
For each subject, measure the amount of cfDNA collected using the BioCaptis device and compare it with the amount of cfDNA obtained from a paired 10mL blood draw in healthy human subjects
Time frame: Immediately after the procedure
For each subject, assess the fragment size profile of cfDNA collected using the BioCaptis and compare it with cfDNA obtained from a paired 10mL blood draw.
Time frame: Immediately after the procedure
For each subject, assess the performance in molecular genetic assays, such as qPCR, of cfDNA obtained using the BioCaptis device and compare it with the performance of cfDNA obtained from a paired 10mL blood draw.
Time frame: Up to 7 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing BioCaptis in people with Healthy, run by BioCaptiva 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 8 inclusion and 7 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 27 Jul 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
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 adverse events profile observed for all participants undergoing the investigational procedure to evaluate the safety of the BioCaptis device. (time frame: Up to 7 days post-procedure). 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 27 Jul 2023.