Coagulation DisorderPhase 1NCT06517563
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
A Phase 1 study testing VMX-C001, Rivaroxaban and UFH in people with Coagulation Disorder, run by VarmX B.V. at 1 site in Netherlands.
Trial summary
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts: UFH cohort: Subjects will be administered 2… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- VMX-C001, Rivaroxaban and UFH
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Aug 2024to 13 Apr 2026
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women of any ethnic origin aged between 18 and 49 years of age, inclusive, at the time of Screening.
- Male subjects must be willing to use appropriate contraception, such as a condom, and to refrain from sperm donation during the main study and until 90 days after study drug administration.
- Women of child-bearing potential must agree not to attempt to become pregnant and to use a highly effective form of birth control during the main study and for 90 days after study drug administration when their sexual partner has not been vasectomized. Highly effective forms of birth control entail the use of combined (estrogen- and progestogen-containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS) or abstinence.
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with documented follicle stimulating hormone [FSH] >33.4 IU/L).
- Surgically sterile women are defined as those who have had a surgical bilateral oophorectomy with or without hysterectomy, total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, the reproductive status of the woman has to be confirmed by follow-up hormone level assessment. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
- Subject must weigh between 60 and 120 kg, inclusive, and must have a BMI between 18.0 and 30.0 kg/m2, inclusive, at Screening and on Day -1.
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- Subject must be in good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations (congenital non hemolytic hyperbilirubinemia is acceptable).
- Subject is willing and able to give their written informed consent to participate in the study and to abide by the study restrictions.
- Subject has good upper limb venous access.
Who cannot join
- The subject has taken tenoxicam in the 35 days prior to Day 1 or has taken piroxicam in the two weeks prior to Day 1.
- The subject is receiving or requires, for any cause, any anticoagulant or antiplatelet therapy including warfarin, clopidogrel or aspirin or any other anticoagulant or antiplatelet agent or has used these therapies in the 4 weeks prior to Day 1.
- The subject has taken any non-aspirin, non-tenoxicam, non-piroxicam non-steroidal antiinflammatory drug (NSAID) in the week prior to Day 1.
- The subject requires or has taken during the 4 weeks prior to Day 1, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g. as part of a multivitamin supplement.
- The subject has received any prescribed oral, systemic or topical medication, including any vaccinations, within 14 days before Day 1 (with the exception of contraceptives), unless in the opinion of the Principal Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- The subject has used any non-prescribed systemic or topical medication (including herbal remedies) within 4 days prior to Day 1 (with the exception of oral vitamin/mineral supplements [including those that contain vitamin K when not taken for therapeutic purposes] and paracetamol), unless in the opinion of the Principal Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
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- The subject has been administered an investigational drug (new chemical or biological entity) within 4 weeks prior to Day 1 for small molecules or within 12 weeks or 5 halflives, whichever is longer, prior to Day 1 for all other types of investigational drug.
- The subject has donated ≥500 mL blood, plasma or platelets in the 12 weeks prior to Screening or the subject has donated any blood amount within 30 days prior to Screening.
- Because of an increased risk of thrombosis, subjects with known diabetes mellitus or a fasted glucose ≥7.0 mmol/l at Screening.
- The subject has any bleeding diathesis, any increased risk of bleeding or, in the opinion of the Principal Investigator, is at increased risk of the consequences of bleeding including but not limited to the following:
- gastro-intestinal ulceration within the last 12 weeks;
- known or suspected oesophageal varices;
- vascular aneurysms or known arteriovenous malformations;
- history of known major intraspinal or intracerebral vascular abnormalities;
- history of brain, spinal or ophthalmic surgery within the last year;
- any intracranial hemorrhage;
- uncontrolled severe hypertension.
- The subject has, in the opinion of the Principal Investigator, any increased risk of thrombosis or thromboembolism including any known thrombophilia, such as antiphospholipid syndrome, or any past history of provoked or unprovoked arterial or venous thrombosis, including thromboembolism.
- The subject has a significant history of drug allergy, as determined by the Principal Investigator.
- The subject has, at Screening or on Day -1, a supine blood pressure or supine pulse rate ≥ 150/95 mmHg and >100 beats per minute (bpm), respectively, or < 90/40 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
- The subject consumes > 21 alcoholic drinks/week for men or > 14 alcoholic drinks/week for women (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1 measure [25 mL] of spirits), or has a significant history of alcoholism or drug/chemical abuse, as determined by the Principal Investigator.
- The subject has a positive drug screen, alcohol test or cotinine test result at Screening or on Day -1, confirmed by repeat testing.
- The female subject has a positive pregnancy test at Screening or on Day -1, or is lactating.
- The subject currently smokes or uses nicotine-containing products. Former smokers will be eligible, provided they have not smoked for at least 4 weeks prior to administration of the study drug.
- The subject has, or has a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematological or other major disorders, as determined by the Principal Investigator.
- The subject has a positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody test result at Screening.
- The subject has an abnormality in the 12-lead ECG at Screening or on Day -1 that, in the judgement of the Principal Investigator may, during the main study, interfere with the interpretation of 12-lead ECG results, including average QTcF interval >450 msec for men or >470 msec for women, 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as average PR<110 msec, confirmed by a triplicate repeat ECG.
- The subject has any other condition that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the subject's ability to comply with the protocol and complete the study.
- The subject has renal insufficiency (serum creatinine level > 1.25 times upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) of <60 mL/minute*1.73m2 at Screening or on Day -1. One re-test is allowed).
- The subject has active liver disease (alanine transaminase [ALT]/ aspartate transaminase [AST] >1.5x ULN, or total bilirubin > 1.5x ULN at Screening or on Day -1. One re-test is allowed).
- The subject has previously participated in a clinical study with VMX-C001.
- The subject has any contra-indication to treatment with heparin (LMWH or UFH).
- Additional exclusion criteria for UFH Cohort only:
- Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives or has received medication that is an inhibitor of P-glycoprotein or CYP3A4. (eg clarithromycin, erythromycin and azole-antimycotics such as ketoconazole, itraconazole, voriconazole and posaconazole or HIV protease inhibitors.) within 30 days prior to Day 1.
- Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives or has received treatment with CYP3A4 inducers (eg St. John's wort, rifampicin, phenytoin, carbamazepine, phenobarbital within 30 days prior to Day 1.
- Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives or has received treatment with selective serotonin reuptake inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs) within 30 days prior to Day 1.
- The subject has any contra-indication to treatment with DOACs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Effects of VMX-C001 in Combination With an Oral FXa DOAC on the Efficacy of Unfractionated Heparin and of VMX-C001 Alone on the Efficacy of Low Molecular Weight Heparin in Healthy Subjects
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts:
UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5.
LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.
- Conditions
- Coagulation Disorder
- Being tested
- VMX-C001, Rivaroxaban, UFH, Enoxaparin
- Keywords
- Direct oral anticoagulant (DOAC), Human coagulation factor X
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMX-C001Drug
VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs
RivaroxabanDrug
FXa Inhibitor
UFHDrug
Unfractionated Heparin
EnoxaparinDrug
Low Molecular Weight Heparin
| Study group | Role | What they receive |
|---|---|---|
| UFH Cohort | Experimental | Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban QD from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5. Receives: Drug: VMX-C001; Drug: Rivaroxaban; Drug: UFH |
| LMWH Cohort | Experimental | Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4. Receives: Drug: VMX-C001; Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thrombin time following dosing with VMX-C001(UFH cohort)
Change from baseline in thrombin time
Measured: Up to Day 6
Change in prothrombin time (PT) following dosing with VMX-C001
Change from baseline in PT
Measured: Up to End of Study (Day 32/33)
Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001
Change from baseline in aPTT
Measured: Up to End of Study (Day 32/33)
Change in fibrinogen following dosing with VMX-C001
Change from baseline in fibrinogen
Measured: Up to End of Study (Day 32/33)
Change in dilute Russell viper venom time (dRVVT) following dosing with VMX-C001(UFH Cohort only)
Change from baseline in dRVVT
Measured: Up to Day 6
Change in dilute prothrombin time (dPT) following dosing with VMX-C001 (UFH Cohort only)
Change from baseline in dPT
Measured: Up to Day 6
Change in thrombin generation following dosing with VMX-C001
Change from baseline in thrombin generation measured by calibrated automated thrombography
Measured: Up to Day 6
Change in real time activated clotting time (ACT) following dosing with VMX-C001 (UFH cohort only)
Change from baseline in ACT
Measured: Up to Day 6
Change in anti-factor 10a (FXa) activity following dosing with VMX-C001 (LMWH Cohort only)
Change from baseline in anti-FXa activity
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start14 Aug 2024
- Primary completion9 Dec 2024
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VarmX B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517563
- Sponsor's protocol ID
- VMX-C001-02
- Other IDs
- 2022-003675-41
- Status last verified
- May 2026
- First submitted
- 19 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Effects of VMX-C001 in Combination With an Oral FXa DOAC on the Efficacy of Unfractionated Heparin and of VMX-C001 Alone on the Efficacy of Low Molecular Weight Heparin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06517563
- Acronym / sponsor ID
- VMX-C001-02
- Conditions
- Coagulation Disorder
- Keywords
- Direct oral anticoagulant (DOAC), Human coagulation factor X
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VarmX B.V.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 24 Jul 2024 (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.
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts:
UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5.
LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UFH Cohort | Experimental | Drug: VMX-C001, Drug: Rivaroxaban, Drug: UFHSubjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban QD from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5. |
| LMWH Cohort | Experimental | Drug: VMX-C001, Drug: EnoxaparinSubjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women of any ethnic origin aged between 18 and 49 years of age, inclusive, at the time of Screening.
- Male subjects must be willing to use appropriate contraception, such as a condom, and to refrain from sperm donation during the main study and until 90 days after study drug administration.
- Women of child-bearing potential must agree not to attempt to become pregnant and to use a highly effective form of birth control during the main study and for 90 days after study drug administration when their sexual partner has not been vasectomized. Highly effective forms of birth control entail the use of combined (estrogen- and progestogen-containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS) or abstinence.
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with documented follicle stimulating hormone [FSH] >33.4 IU/L).
- Surgically sterile women are defined as those who have had a surgical bilateral oophorectomy with or without hysterectomy, total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, the reproductive status of the woman has to be confirmed by follow-up hormone level assessment. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
Key exclusion criteria (37 listed)
- The subject has taken tenoxicam in the 35 days prior to Day 1 or has taken piroxicam in the two weeks prior to Day 1.
- The subject is receiving or requires, for any cause, any anticoagulant or antiplatelet therapy including warfarin, clopidogrel or aspirin or any other anticoagulant or antiplatelet agent or has used these therapies in the 4 weeks prior to Day 1.
- The subject has taken any non-aspirin, non-tenoxicam, non-piroxicam non-steroidal antiinflammatory drug (NSAID) in the week prior to Day 1.
- The subject requires or has taken during the 4 weeks prior to Day 1, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g. as part of a multivitamin supplement.
- The subject has received any prescribed oral, systemic or topical medication, including any vaccinations, within 14 days before Day 1 (with the exception of contraceptives), unless in the opinion of the Principal Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
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 |
|---|---|---|
| VMX-C001VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs | Drug | LMWH Cohort, UFH Cohort |
| RivaroxabanFXa Inhibitor | Drug | UFH Cohort |
| UFHUnfractionated Heparin | Drug | UFH Cohort |
| EnoxaparinLow Molecular Weight Heparin | Drug | LMWH Cohort |
Primary outcome
Change in thrombin time following dosing with VMX-C001(UFH cohort)
Time frame: Up to Day 6
Change from baseline in thrombin time
Change in prothrombin time (PT) following dosing with VMX-C001
Time frame: Up to End of Study (Day 32/33)
Change from baseline in PT
Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001
Time frame: Up to End of Study (Day 32/33)
Change from baseline in aPTT
Change in fibrinogen following dosing with VMX-C001
Time frame: Up to End of Study (Day 32/33)
Change from baseline in fibrinogen
Change in dilute Russell viper venom time (dRVVT) following dosing with VMX-C001(UFH Cohort only)
Time frame: Up to Day 6
Change from baseline in dRVVT
Change in dilute prothrombin time (dPT) following dosing with VMX-C001 (UFH Cohort only)
Time frame: Up to Day 6
Change from baseline in dPT
Change in thrombin generation following dosing with VMX-C001
Time frame: Up to Day 6
Change from baseline in thrombin generation measured by calibrated automated thrombography
Change in real time activated clotting time (ACT) following dosing with VMX-C001 (UFH cohort only)
Time frame: Up to Day 6
Change from baseline in ACT
Change in anti-factor 10a (FXa) activity following dosing with VMX-C001 (LMWH Cohort only)
Time frame: Up to Day 6
Change from baseline in anti-FXa activity
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 May 2026.
- 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 VMX-C001, Rivaroxaban and UFH in people with Coagulation Disorder, run by VarmX B.V. at 1 site in Netherlands.
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 9 inclusion and 37 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 May 2026. 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 Netherlands. 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?
Change in thrombin time following dosing with VMX-C001(UFH cohort) (time frame: Up to Day 6). The study lists 9 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 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.