HealthyPhase 1NCT04653766
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects
A Phase 1 study testing Ir-CPI - Dose 1, Ir-CPI - Dose 2 and Ir-CPI - Dose 3 in people with Healthy, run by Bioxodes S.A. at 1 site in Belgium.
Trial summary
The purpose of this First-in-Human study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ir-CPI, a novel dual inhibitor of FXIIa and FXIa, following IV administration of single ascending doses in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ir-CPI - Dose 1, Ir-CPI - Dose 2 and Ir-CPI - Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2019to 4 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must satisfy all of the following inclusion criteria before being allowed to enter the study:
- Have given written informed consent approved by the relevant Ethics Committee (EC) governing the site, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Male participants between 18 and 55 years of age, inclusive at screening.
- Otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, haematological assessments, coagulation and urinalysis, measurement of vital signs, and ECG. Isolated out-of-range values judged by the PI (or designated physician) to be of no clinical significance can be allowed. This determination must be recorded in the participant's source documents.
- Have a body weight in the range of 50 to 90 kg inclusive at screening. Have a body mass index (BMI) of 19 to 28 kg/m2 inclusive at screening.
- Agree to abstain from alcohol intake 24 hours before administration of study drug, during the in-patient period of the study and 24 hours prior to all other ambulatory visits, up until and including the discharge visit.
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- Agree not to use prescription medications within 14 days prior to study drug administration and through the duration of the study, unless approved by the PI and Sponsor medical monitor.
- Non-smokers or abstinence from tobacco or nicotine-containing products for at least 3 months prior to screening.
- Agree not to use over-the-counter (OTC) medications [including decongestants, antihistamines, and herbal medication (including herbal tea and St. John's Wort)], within 14 days prior to study drug administration through the discharge visit, unless approved by the PI and Sponsor medical monitor. Occasional use of paracetamol at recommended doses is allowed. Special rules apply for aspirin, corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS (see exclusion criteria 6-7-8-9)
- Venous access (both arms) sufficient to allow blood sampling and study drug administration as per protocol.
- Participants and their partners of childbearing potential [meaning who are not surgically sterile (tubal ligation/obstruction or removal of ovaries or uterus) or post-menopausal (absence of menstrual periods for at least 12 consecutive months)] must be willing to use 2 methods of contraception: - a highly effective method of birth control starting at screening. Highly effective methods of birth control are defined as those that result in a low failure rate (i.e. Pearl Index less than 1% per year) when used consistently and correctly, such as implants, rings, patches, injectable or combined oral contraceptives, intrauterine devices (IUDs), or sexual abstinence (periodic abstinence e.g. calendar, ovulation, symptothermal, postovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception) . - and a local barrier form of contraception. Acceptable barrier methods are either the participant's use of a condom or the partner's use of an occlusive cap or diaphragm, or spermicides. Participants will not donate sperm from the selection visit and up to 90 days after the infusion. In case of sterile or vasectomised participants, no contraception will be required for their partners of childbearing potential.
- Willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol.
Who cannot join
- If any of the following exclusion criteria apply, the participant must not enter the study:
- Currently have or have a history of any clinically significant medical illness or medical disorders the PI considers should exclude the participant, including (but not limited to) cardiovascular disease, neuromuscular, haematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
- History of personal or familial bleeding disorders; including prolonged or unusual bleeding.
- History of deficiency in factor XII (FXII) or haemophilia type A (FVII) or type B (FIX) or type C (FXI).
- History of cerebral bleeding (e.g. after a car accident), stroke and cerebrovascular accident (CVA).
- Anamnestic history of Lyme disease or tick-borne encephalitis.
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- Use of Acetylsalicylic-Acid (ASA)-containing OTC medications within 1 month prior to screening.
- Chronic administration of NSAIDs, chronic use of corticosteroids within 1 month prior to screening.
- Chronic administration of clopidogrel, ticlopidin, dipyridamole, Coumadin-like anticoagulants, new oral anticoagulant dabigatran, rivaroxaban, apixaban or edoxaban within 3 months prior to screening.
- Administration of unfractionated heparin, low molecular weight heparin, fibrinolytic agents and anti-FXa within 3 months prior to screening.
- Have an active acute or chronic infection or diagnosed latent infection.
- Systolic blood pressure (SBP) greater than 150 or less than 90 mmHg, diastolic blood pressure (DBP) greater than 90 or less than 50 mmHg, and heart rate (HR) greater than 100 or less than 40 bpm.
- Acute clinically relevant illness within 7 days prior to study drug administration or have had a major illness or hospitalisation within 1 month prior to study drug administration.
- Major or traumatic surgery within 12 weeks of screening.
- Any participant who plans to undergo elective surgery within 4 weeks prior to study drug administration and through the discharge visit.
- Positive serology test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
- Recent history (within previous 6 months) of alcohol or drug abuse.
- Have positive urine toxicology screen at screening or D -1 for substances of abuse including amphetamines, benzodiazepine, cocaine, opiates, barbiturate and cannabinoids.
- Have a positive alcohol breath test at screening or D-1.
- Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of caffeine-containing soda or other caffeinated products per day).
- Donated blood (i.e. 500 mL) within 3 months before D1.
- Have a history of active drug and/or food allergy or other active allergic disease requiring the constant use of medications, or a history of severe allergic reaction, angioedema or anaphylaxis.
- Received any other experimental therapy or new investigational drug within 30 days or 5 half-lives (whichever is longer) of study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double Blind, Placebo Controlled, Single Ascending Dose Study of Intravenously Administered Ir-CPI to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Healthy Male Volunteers
The purpose of this First-in-Human study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ir-CPI, a novel dual inhibitor of FXIIa and FXIa, following IV administration of single ascending doses in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Ir-CPI - Dose 1, Ir-CPI - Dose 2, Ir-CPI - Dose 3, Ir-CPI - Dose 4, Placebo
- Keywords
- Antithrombotic, Intrinsic coagulation pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ir-CPI - Dose 1Drug
6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
Ir-CPI - Dose 2Drug
6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
Ir-CPI - Dose 3Drug
6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
Ir-CPI - Dose 4Drug
6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
PlaceboDrug
For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
| Study group | Role | What they receive |
|---|---|---|
| Ir-CPI - Dose 1 | Experimental | Participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours Receives: Drug: Ir-CPI - Dose 1 |
| Ir-CPI - Dose 2 | Experimental | Participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours Receives: Drug: Ir-CPI - Dose 2 |
| Ir-CPI - Dose 3 | Experimental | Participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours Receives: Drug: Ir-CPI - Dose 3 |
| Ir-CPI - Dose 4 | Experimental | Participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours Receives: Drug: Ir-CPI - Dose 4 |
| Placebo | Placebo comparator | Participants received a single intravenous dose of placebo during 6 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
These safety aPTT results were readily available to the PI for safety follow-up during and after the study drug administration. Safety aPTT was followed up "at the bedside" at regular time-points (as opposed to the PD biomarker aPTT, which was assessed by the central laboratory alongside the PK time-points). An aPTT ratio was calculated by dividing the aPTT value (in sec) of the specific time-point (aPTTt) by the baseline aPTT value (in sec) (aPTTbaseline) of the same participant (aPTT ratio = aPTTt/aPTTbaseline). The baseline time-point was considered as having an aPTT ratio of 1.
Concerning the row titles, for example, Day 1 H02:00 corresponds to aPTT ratio results obtained on Day 1, 2 hours after the start of the infusion.
Measured: At pre-dose (baseline), 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Secondary outcomes (6)
Measurement of the Maximum Plasma Concentration (Cmax) of Ir-CPI
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)
Measurement of the Time to Reach Maximum Plasma Concentration (Tmax) of Ir-CPI
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)
Measurement of the Area Under the Plasma Concentration-time Curve From Time Zero to 6h (AUC0-6) and From Time Zero to Time of Infinity (AUCinf)
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
The activated partial thromboplastin time (aPTT) is used as a pharmacodynamic marker. No data were available for the Ir-CPI 1.5 mg/kg group because the results were not usable due to plasma preparation and method repeatability problems. An aPTT ratio was calculated by dividing the aPTT value (in sec) of the specific time-point (aPTTt) by the baseline aPTT value (in sec) (aPTTbaseline) of the same participant (aPTT ratio = aPTTt/aPTTbaseline). The baseline time-point (Day 1 H00:00) was considered as having an aPTT ratio of 1.
Concerning the row titles, for example, Day 1 H02:00 corresponds to aPTT ratio results obtained on Day 1, 2 hours after the start of the infusion.
Measured: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Measurement of the Effect of Ir-CPI on Factor XI Activity
The method is a clotting assay where all the clotting factors are present (constant and in excess, brought by the deficient plasma), excepted for FXI, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (aPTT). FXI is the limiting factor and clotting time is inversely proportional to the concentration of FXI. There is an inverse linear relationship between the percentage of FXI activity and the corresponding clotting time. Central laboratory normal ranges for Factor XI activity are between 65 and 150 %.
Concerning the row titles, for example, Day 1 H02:00 corresponds to the percentage of FXI activity obtained on Day 1, 2 hours after the start of the infusion.
Measured: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Measurement of the Effect of Ir-CPI on Factor XII Activity
The method is a clotting assay where all the clotting factors are present (constant and in excess, brought by the deficient plasma), excepted for FXII, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (aPTT). FXII is the limiting factor and clotting time is inversely proportional to the concentration of FXII. There is an inverse linear relationship between the percentage of FXII activity and the corresponding clotting time. Central laboratory normal ranges for Factor XII activity are between 50 and 150 %.
Concerning the row titles, for example, Day 1 H02:00 corresponds to the percentage of FXII activity obtained on Day 1, 2 hours after the start of the infusion.
Measured: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start12 Sep 2019
- Primary completion18 Jul 2020
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioxodes S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653766
- Sponsor's protocol ID
- Clin_IrCPI_101
- Other IDs
- 2019-002305-22, 2019
- Status last verified
- Feb 2023
- First submitted
- 29 Oct 2020
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Placebo Controlled, Single Ascending Dose Study of Intravenously Administered Ir-CPI to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04653766
- Acronym / sponsor ID
- Clin_IrCPI_101
- Conditions
- Healthy
- Keywords
- Antithrombotic, Intrinsic coagulation pathway
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bioxodes S.A.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this First-in-Human study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ir-CPI, a novel dual inhibitor of FXIIa and FXIa, following IV administration of single ascending doses in healthy male volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ir-CPI - Dose 1 | Experimental | Drug: Ir-CPI - Dose 1Participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours |
| Ir-CPI - Dose 2 | Experimental | Drug: Ir-CPI - Dose 2Participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours |
| Ir-CPI - Dose 3 | Experimental | Drug: Ir-CPI - Dose 3Participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours |
| Ir-CPI - Dose 4 | Experimental | Drug: Ir-CPI - Dose 4Participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single intravenous dose of placebo during 6 hours |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participants must satisfy all of the following inclusion criteria before being allowed to enter the study:
- Have given written informed consent approved by the relevant Ethics Committee (EC) governing the site, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Male participants between 18 and 55 years of age, inclusive at screening.
- Otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, haematological assessments, coagulation and urinalysis, measurement of vital signs, and ECG. Isolated out-of-range values judged by the PI (or designated physician) to be of no clinical significance can be allowed. This determination must be recorded in the participant's source documents.
- Have a body weight in the range of 50 to 90 kg inclusive at screening. Have a body mass index (BMI) of 19 to 28 kg/m2 inclusive at screening.
Key exclusion criteria (23 listed)
- If any of the following exclusion criteria apply, the participant must not enter the study:
- Currently have or have a history of any clinically significant medical illness or medical disorders the PI considers should exclude the participant, including (but not limited to) cardiovascular disease, neuromuscular, haematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
- History of personal or familial bleeding disorders; including prolonged or unusual bleeding.
- History of deficiency in factor XII (FXII) or haemophilia type A (FVII) or type B (FIX) or type C (FXI).
- History of cerebral bleeding (e.g. after a car accident), stroke and cerebrovascular accident (CVA).
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 |
|---|---|---|
| Ir-CPI - Dose 16 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours | Drug | Ir-CPI - Dose 1 |
| Ir-CPI - Dose 26 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours | Drug | Ir-CPI - Dose 2 |
| Ir-CPI - Dose 36 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours | Drug | Ir-CPI - Dose 3 |
| Ir-CPI - Dose 46 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours | Drug | Ir-CPI - Dose 4 |
| PlaceboFor each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total). | Drug | Placebo |
Primary outcome
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Time frame: At pre-dose (baseline), 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose and at the discharge visit (Day 10 ± 2 days)
These safety aPTT results were readily available to the PI for safety follow-up during and after the study drug administration. Safety aPTT was followed up "at the bedside" at regular time-points (as opposed to the PD biomarker aPTT, which was assessed by the central laboratory alongside the PK time-points). An aPTT ratio was calculated by dividing the aPTT value (in sec) of the specific time-point (aPTTt) by the baseline aPTT value (in sec) (aPTTbaseline) of the same participant (aPTT ratio = aPTTt/aPTTbaseline). The baseline time-point was considered as having an aPTT ratio of 1. Concerning the row titles, for example, Day 1 H02:00 corresponds to aPTT ratio results obtained on Day 1, 2 hours after the start of the infusion.
6 secondary outcomes
Measurement of the Maximum Plasma Concentration (Cmax) of Ir-CPI
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)
Measurement of the Time to Reach Maximum Plasma Concentration (Tmax) of Ir-CPI
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)
Measurement of the Area Under the Plasma Concentration-time Curve From Time Zero to 6h (AUC0-6) and From Time Zero to Time of Infinity (AUCinf)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Time frame: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Measurement of the Effect of Ir-CPI on Factor XI Activity
Time frame: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Measurement of the Effect of Ir-CPI on Factor XII Activity
Time frame: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ir-CPI - Dose 1, Ir-CPI - Dose 2 and Ir-CPI - Dose 3 in people with Healthy, run by Bioxodes S.A. at 1 site in Belgium.
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 12 inclusion and 23 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 23 Feb 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT) (time frame: At pre-dose (baseline), 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose and at the discharge visit (Day 10 ± 2 days)). 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 23 Feb 2023.