A First-in-human Trial to Assess the Safety and Performance of the BioCaptis in Healthy Volunteers

NCT05813041 | Unknown

• 1 other identifier: BioCaptis-1
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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.

  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.

  Up to 7 days post-procedure

Study Arms (1)

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.

Device: BioCaptis

Interventions

BioCaptis DEVICE

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.

Investigational Device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioCaptiva Ltd.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical investigation of the safety and performance of a medical device. Single site, single arm, open label, healthy volunteer.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: April 14, 2023
• Study Start: July 31, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share