Coagulation DisorderPhase 1NCT06372483
Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant
A Phase 1 study testing VMX-C001, Rivaroxaban 20 mg Oral Tablet and Apixaban 5 mg Oral Tablet in people with Coagulation Disorder, run by VarmX B.V. at 1 site in Netherlands.
Trial summary
A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: Part 1: Single dose of VMX-C001 or placebo in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- VMX-C001, Rivaroxaban 20 mg Oral Tablet and Apixaban 5 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Feb 2024to 26 Aug 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In Part 1, men and women of any ethnic origin between 18 and 49 years of age, in Part 2, men and women of any ethnic origin between 50 and 79 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 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 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 the first administration of study drug or FXa DOAC or has taken piroxicam in the two weeks prior to the first administration of study drug or FXa DOAC.
- The subject has taken any non-aspirin, non-piroxicam, non-steroidal anti-inflammatory drug (NSAID) in the week prior to the first administration of study drug or FXa DOAC.
- The subject requires or has taken during the month prior to first administration of study drug or FXa DOAC, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g., as part of a multivitamin supplement.
- 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 month prior to the first administration of study drug or FXa DOAC.
- The subject has received any prescribed oral, systemic or topical medication, including any vaccinations, within 14 days prior to the first administration of study drug or FXa DOAC (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 one week prior to the first administration of study drug or FXa DOAC (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 is currently participating in a clinical study, e.g. attending follow-up visits or has been administered an investigational drug (new chemical or biological entity) within 1 month (for small molecules) or 3 months (for biologicals) prior to administration of the study drug.
- The subject has donated ≥500 mL blood, plasma, or platelets in the 3 months prior to Screening or any other 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 3 months;
- 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.
- For Part 1, 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. For Part 2, the subject consumes >14 alcoholic drinks/week 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 1 month 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 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/min*1.73m2).
- The subject has active liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [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.
- Additional exclusion criteria for Part 2 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. (e.g., clarithromycin, erythromycin and azole-antimycotics such as ketoconazole, itraconazole, voriconazole and osaconazole or HIV protease inhibitors.) within 30 days prior to first administration of FXa DOAC.
- Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives or has received treatment with CYP3A4 inducers (e.g., St. John's wort, rifampicin, phenytoin, carbamazepine, phenobarbital) within 30 days prior to first administration of FXa DOAC.
- 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 first administration of FXa DOAC.
- The subject has any contra-indication to treatment with FXa DOACs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single Dose Trial Evaluating Different Doses of Intravenously Administered VMX-C001 and to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VMX-C001 in Healthy Subjects (Part 1) and in Combination With a Selected FXa Direct Oral Anticoagulant (DOAC) in Healthy Older Subjects (Part 2)
A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:
Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.
Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects.
- Conditions
- Coagulation Disorder
- Being tested
- VMX-C001, Placebo, Rivaroxaban 20 mg Oral Tablet, Apixaban 5 mg Oral Tablet, Edoxaban 60 mg Oral Tablet
- 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
PlaceboDrug
VMX-C001 matched placebo
Rivaroxaban 20 mg Oral TabletDrug
Fxa DOAC
Apixaban 5 mg Oral TabletDrug
Fxa DOAC
Edoxaban 60 mg Oral TabletDrug
Fxa DOAC
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort 1:1 - VMX-C001 | Experimental | Single dose active. Receives: Drug: VMX-C001 |
| Part 1, Cohort 1:1 - Placebo | Placebo comparator | Single dose placebo. Receives: Drug: Placebo |
| Part 2, Cohort 2:1 - VMX-C001 + Rivaroxaban | Experimental | Single dose active in combination with DOAC. Receives: Drug: VMX-C001; Drug: Rivaroxaban 20 mg Oral Tablet |
| Part 2, Cohort 2:1 - Placebo + Rivaroxaban | Placebo comparator | Single dose placebo in combination with DOAC. Receives: Drug: Placebo; Drug: Rivaroxaban 20 mg Oral Tablet |
| Part 2, Cohort 2:2 - VMX-C001 + DOAC | Experimental | Optional cohort - Single dose active in combination with selected DOAC. Receives: Drug: VMX-C001; Drug: Rivaroxaban 20 mg Oral Tablet; Drug: Apixaban 5 mg Oral Tablet; Drug: Edoxaban 60 mg Oral Tablet |
| Part 2, Cohort 2:2 - Placebo + DOAC | Placebo comparator | Optional cohort - Single dose placebo in combination with selected DOAC. Receives: Drug: Placebo; Drug: Rivaroxaban 20 mg Oral Tablet; Drug: Apixaban 5 mg Oral Tablet; Drug: Edoxaban 60 mg Oral Tablet |
| Part 2, Cohort 2:3 - VMX-C001 + DOAC | Experimental | Optional cohort - Single dose active in combination with selected DOAC. Receives: Drug: VMX-C001; Drug: Rivaroxaban 20 mg Oral Tablet; Drug: Apixaban 5 mg Oral Tablet; Drug: Edoxaban 60 mg Oral Tablet |
| Part 2, Cohort 2:3 - Placebo + DOAC | Placebo comparator | Optional cohort - Single dose placebo in combination with selected DOAC. Receives: Drug: Placebo; Drug: Rivaroxaban 20 mg Oral Tablet; Drug: Apixaban 5 mg Oral Tablet; Drug: Edoxaban 60 mg Oral Tablet |
| Part 2, Cohort 2:4 - VMX-C001 + DOAC | Experimental | Optional cohort - Single dose active in combination with selected DOAC. Receives: Drug: VMX-C001; Drug: Rivaroxaban 20 mg Oral Tablet; Drug: Apixaban 5 mg Oral Tablet; Drug: Edoxaban 60 mg Oral Tablet |
| Part 2, Cohort 2:4 - Placebo + DOAC | Placebo comparator | Optional cohort - Single dose placebo in combination with selected DOAC. Receives: Drug: Placebo; Drug: Rivaroxaban 20 mg Oral Tablet; Drug: Apixaban 5 mg Oral Tablet; Drug: Edoxaban 60 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1)
Number of Subjects with One of More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: From dosing up to Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2)
Number of Subjects with One of More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: From dosing up to Day 31
PK of VMX-C001 in plasma - Cmax
Maximal concentration in plasma
Measured: Up to 7 days post VMX-C001 dose
PK of VMX-C001 in plasma - tmax
Time of maximal concentration in plasma
Measured: Up to 7 days post VMX-C001 dose
PK of VMX-C001 in plasma - t1/2
Terminal elimination half-life in plasma
Measured: Up to 7 days post VMX-C001dose
PK of VMX-C001 in plasma - AUC0-last
Area under the concentration-time curve from time of dosing to last measurable concentration in plasma
Measured: Up to 7 days post VMX-C001 dose
PK of VMX-C001 in plasma - AUC0-inf
Area under the concentration-time curve from time of dosing extrapolated to infinity in plasma
Measured: Up to 7 days post VMX-C001 dose
PK of VMX-C001 in plasma - Lambda z
Terminal elimination rate constant
Measured: Up to 7 days post VMX-C001 dose
PK of VMX-C001 in plasma - CL
Total body clearance
Measured: Up to 7 days post VMX-C001 dose
PK of VMX-C001 in plasma - Vz
Apparent volume of distribution
Measured: Up to 7 days post VMX-C001 dose
DOAC plasma concentrations (Part 2)
Measured: Up to Day 10
Change in Prothrombin time (PT) following dosing with VMX-C001
Measured: Up to 7 days post VMX-C001 dose
Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001
Measured: Up to 7 days post VMX-C001 dose
Change in D-dimer following dosing with VMX-C001
Measured: Up to 7 days post VMX-C001 dose
Change in prothrombin fragments F1 and 2 following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in thrombin generation, measured by lag time, following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in thrombin generation, measured by peak height, following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in thrombin generation, measured by time to peak, following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in thrombin generation, measured by velocity index, following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in thrombin generation, measured by time to tail, following dosing with VMX-C001
Mean and median values, subjects on active treatment per group versus placebo
Measured: Up to 7 days post VMX-C001 dose
Change in diluted prothrombin time (dPT) following dosing with VMX-C001
Measured: Up to 7 days post VMX-C001 dose
Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001
Measured: Up to 7 days post VMX-C001 dose
Change in real time activated clotting time (ACT) following dosing with VMX-C001
Measured: Up to 7 days post VMX-C001 dose
Secondary outcomes (2)
Antibodies against VMX-C001 in plasma
Percentage of patients positive (active vs placebo), and titer (percentage of patients tested positive for each titer measured)
Measured: Up to 28 days post VMX-C001 dose
Antibodies against human coagulation FX in plasma
Percentage of patients positive (active vs placebo), and titer (percentage of patients tested positive for each titer measured)
Measured: Up to 28 days post VMX-C001 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start21 Feb 2024
- Primary completion7 Aug 2024
- Study completion26 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled, single dose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT06372483
- Sponsor's protocol ID
- VMX-C001-03
- Other IDs
- 2023-507059-32-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Single Dose Trial Evaluating Different Doses of Intravenously Administered VMX-C001 and to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VMX-C001 in Healthy Subjects (Part 1) and in Combination With a Selected FXa Direct Oral Anticoagulant (DOAC) in Healthy Older Subjects (Part 2)
- ClinicalTrials.gov ID
- NCT06372483
- Acronym / sponsor ID
- VMX-C001-03
- Conditions
- Coagulation Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VarmX B.V.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 18 Apr 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, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:
Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.
Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
- Model description
- Placebo controlled, single dose.
| Arm | Type | Receives |
|---|---|---|
| Part 1, Cohort 1:1 - VMX-C001 | Experimental | Drug: VMX-C001Single dose active. |
| Part 1, Cohort 1:1 - Placebo | Placebo comparator | Drug: PlaceboSingle dose placebo. |
| Part 2, Cohort 2:1 - VMX-C001 + Rivaroxaban | Experimental | Drug: VMX-C001, Drug: Rivaroxaban 20 mg Oral TabletSingle dose active in combination with DOAC. |
| Part 2, Cohort 2:1 - Placebo + Rivaroxaban | Placebo comparator | Drug: Placebo, Drug: Rivaroxaban 20 mg Oral TabletSingle dose placebo in combination with DOAC. |
| Part 2, Cohort 2:2 - VMX-C001 + DOAC | Experimental | Drug: VMX-C001, Drug: Rivaroxaban 20 mg Oral Tablet, Drug: Apixaban 5 mg Oral Tablet, Drug: Edoxaban 60 mg Oral TabletOptional cohort - Single dose active in combination with selected DOAC. |
| Part 2, Cohort 2:2 - Placebo + DOAC | Placebo comparator | Drug: Placebo, Drug: Rivaroxaban 20 mg Oral Tablet, Drug: Apixaban 5 mg Oral Tablet, Drug: Edoxaban 60 mg Oral TabletOptional cohort - Single dose placebo in combination with selected DOAC. |
| Part 2, Cohort 2:3 - VMX-C001 + DOAC | Experimental | Drug: VMX-C001, Drug: Rivaroxaban 20 mg Oral Tablet, Drug: Apixaban 5 mg Oral Tablet, Drug: Edoxaban 60 mg Oral TabletOptional cohort - Single dose active in combination with selected DOAC. |
| Part 2, Cohort 2:3 - Placebo + DOAC | Placebo comparator | Drug: Placebo, Drug: Rivaroxaban 20 mg Oral Tablet, Drug: Apixaban 5 mg Oral Tablet, Drug: Edoxaban 60 mg Oral TabletOptional cohort - Single dose placebo in combination with selected DOAC. |
| Part 2, Cohort 2:4 - VMX-C001 + DOAC | Experimental | Drug: VMX-C001, Drug: Rivaroxaban 20 mg Oral Tablet, Drug: Apixaban 5 mg Oral Tablet, Drug: Edoxaban 60 mg Oral TabletOptional cohort - Single dose active in combination with selected DOAC. |
| Part 2, Cohort 2:4 - Placebo + DOAC | Placebo comparator | Drug: Placebo, Drug: Rivaroxaban 20 mg Oral Tablet, Drug: Apixaban 5 mg Oral Tablet, Drug: Edoxaban 60 mg Oral TabletOptional cohort - Single dose placebo in combination with selected DOAC. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In Part 1, men and women of any ethnic origin between 18 and 49 years of age, in Part 2, men and women of any ethnic origin between 50 and 79 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 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 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 (36 listed)
- The subject has taken tenoxicam in the 35 days prior to the first administration of study drug or FXa DOAC or has taken piroxicam in the two weeks prior to the first administration of study drug or FXa DOAC.
- The subject has taken any non-aspirin, non-piroxicam, non-steroidal anti-inflammatory drug (NSAID) in the week prior to the first administration of study drug or FXa DOAC.
- The subject requires or has taken during the month prior to first administration of study drug or FXa DOAC, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g., as part of a multivitamin supplement.
- 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 month prior to the first administration of study drug or FXa DOAC.
- The subject has received any prescribed oral, systemic or topical medication, including any vaccinations, within 14 days prior to the first administration of study drug or FXa DOAC (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 | Part 1, Cohort 1:1 - VMX-C001, Part 2, Cohort 2:1 - VMX-C001 + Rivaroxaban, Part 2, Cohort 2:2 - VMX-C001 + DOAC, Part 2, Cohort 2:3 - VMX-C001 + DOAC, Part 2, Cohort 2:4 - VMX-C001 + DOAC |
| PlaceboVMX-C001 matched placebo | Drug | Part 1, Cohort 1:1 - Placebo, Part 2, Cohort 2:1 - Placebo + Rivaroxaban, Part 2, Cohort 2:2 - Placebo + DOAC, Part 2, Cohort 2:3 - Placebo + DOAC, Part 2, Cohort 2:4 - Placebo + DOAC |
| Rivaroxaban 20 mg Oral TabletFxa DOAC | Drug | Part 2, Cohort 2:1 - Placebo + Rivaroxaban, Part 2, Cohort 2:1 - VMX-C001 + Rivaroxaban, Part 2, Cohort 2:2 - Placebo + DOAC, Part 2, Cohort 2:2 - VMX-C001 + DOAC, Part 2, Cohort 2:3 - Placebo + DOAC, Part 2, Cohort 2:3 - VMX-C001 + DOAC, Part 2, Cohort 2:4 - Placebo + DOAC, Part 2, Cohort 2:4 - VMX-C001 + DOAC |
| Apixaban 5 mg Oral TabletFxa DOAC | Drug | Part 2, Cohort 2:2 - Placebo + DOAC, Part 2, Cohort 2:2 - VMX-C001 + DOAC, Part 2, Cohort 2:3 - Placebo + DOAC, Part 2, Cohort 2:3 - VMX-C001 + DOAC, Part 2, Cohort 2:4 - Placebo + DOAC, Part 2, Cohort 2:4 - VMX-C001 + DOAC |
| Edoxaban 60 mg Oral TabletFxa DOAC | Drug | Part 2, Cohort 2:2 - Placebo + DOAC, Part 2, Cohort 2:2 - VMX-C001 + DOAC, Part 2, Cohort 2:3 - Placebo + DOAC, Part 2, Cohort 2:3 - VMX-C001 + DOAC, Part 2, Cohort 2:4 - Placebo + DOAC, Part 2, Cohort 2:4 - VMX-C001 + DOAC |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1)
Time frame: From dosing up to Day 28
Number of Subjects with One of More Drug Related Adverse Events (AEs) or any Serious AEs
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2)
Time frame: From dosing up to Day 31
Number of Subjects with One of More Drug Related Adverse Events (AEs) or any Serious AEs
PK of VMX-C001 in plasma - Cmax
Time frame: Up to 7 days post VMX-C001 dose
Maximal concentration in plasma
PK of VMX-C001 in plasma - tmax
Time frame: Up to 7 days post VMX-C001 dose
Time of maximal concentration in plasma
PK of VMX-C001 in plasma - t1/2
Time frame: Up to 7 days post VMX-C001dose
Terminal elimination half-life in plasma
PK of VMX-C001 in plasma - AUC0-last
Time frame: Up to 7 days post VMX-C001 dose
Area under the concentration-time curve from time of dosing to last measurable concentration in plasma
PK of VMX-C001 in plasma - AUC0-inf
Time frame: Up to 7 days post VMX-C001 dose
Area under the concentration-time curve from time of dosing extrapolated to infinity in plasma
PK of VMX-C001 in plasma - Lambda z
Time frame: Up to 7 days post VMX-C001 dose
Terminal elimination rate constant
PK of VMX-C001 in plasma - CL
Time frame: Up to 7 days post VMX-C001 dose
Total body clearance
PK of VMX-C001 in plasma - Vz
Time frame: Up to 7 days post VMX-C001 dose
Apparent volume of distribution
DOAC plasma concentrations (Part 2)
Time frame: Up to Day 10
Change in Prothrombin time (PT) following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Change in D-dimer following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Change in prothrombin fragments F1 and 2 following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in thrombin generation, measured by lag time, following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in thrombin generation, measured by peak height, following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in thrombin generation, measured by time to peak, following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in thrombin generation, measured by velocity index, following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in thrombin generation, measured by time to tail, following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Mean and median values, subjects on active treatment per group versus placebo
Change in diluted prothrombin time (dPT) following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
Change in real time activated clotting time (ACT) following dosing with VMX-C001
Time frame: Up to 7 days post VMX-C001 dose
2 secondary outcomes
Antibodies against VMX-C001 in plasma
Time frame: Up to 28 days post VMX-C001 dose
Antibodies against human coagulation FX in plasma
Time frame: Up to 28 days post VMX-C001 dose
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 9 Sep 2026.
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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 20 mg Oral Tablet and Apixaban 5 mg Oral Tablet 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 36 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 9 Sep 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. 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?
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1) (time frame: From dosing up to Day 28). The study lists 24 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 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.