Single Dose Trial of VMX-C001 in Healthy Subjects with and Without FXa Direct Oral Anticoagulant

Inclusion Criteria:

1. In Part 1, men and women of any ethnic origin between 18 and 49 years of age, inPart 2, men and women of any ethnic origin between 50 and 79 years of age,inclusive, at the time of Screening.

2. 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 studydrug administration.

3. Women of child-bearing potential must agree not to attempt to become pregnant and touse a highly effective form of birth control during the study and for 90 days afterstudy drug administration when their sexual partner has not been vasectomized.Highly effective forms of birth control entail the use of combined (estrogen- andprogestogen-containing) or progestogen-only hormonal contraception associated withinhibition of ovulation, an intrauterine device (IUD), an intrauterinehormone-releasing system (IUS) or abstinence.

4. Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (withdocumented follicle-stimulating hormone (FSH) >33.4 IU/L).

5. Surgically sterile women are defined as those who have had a surgical bilateraloophorectomy with or without hysterectomy, total hysterectomy or tubal ligation atleast six weeks before taking study treatment. In case of oophorectomy alone, thereproductive status of the woman has to be confirmed by follow-up hormone levelassessment. Women who are surgically sterile must provide documentation of theprocedure by an operative report or by ultrasound.

6. 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.

7. Subject must be in good health, as determined by a medical history, physicalexamination, 12-lead ECG, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia is acceptable).

8. Subject is willing and able to give their written informed consent to participate inthe study and to abide by the study restrictions.

9. Subject has good upper limb venous access.

Exclusion Criteria:

1. The subject has taken tenoxicam in the 35 days prior to the first administration ofstudy drug or FXa DOAC or has taken piroxicam in the two weeks prior to the firstadministration of study drug or FXa DOAC.

2. The subject has taken any non-aspirin, non-piroxicam, non-steroidalanti-inflammatory drug (NSAID) in the week prior to the first administration ofstudy drug or FXa DOAC.

3. The subject requires or has taken during the month prior to first administration ofstudy drug or FXa DOAC, vitamin K for therapeutic reasons. Vitamin K not taken fortherapeutic purposes is acceptable, e.g., as part of a multivitamin supplement.

4. The subject is receiving or requires, for any cause, any anticoagulant orantiplatelet therapy including warfarin, clopidogrel or aspirin or any otheranticoagulant or antiplatelet agent or has used these therapies in the month priorto the first administration of study drug or FXa DOAC.

5. The subject has received any prescribed oral, systemic or topical medication,including any vaccinations, within 14 days prior to the first administration ofstudy drug or FXa DOAC (with the exception of contraceptives), unless in the opinionof the Principal Investigator and the Medical Monitor the medication will notinterfere with the study procedures or compromise safety.

6. The subject has used any non-prescribed systemic or topical medication (includingherbal remedies) within one week prior to the first administration of study drug orFXa DOAC (with the exception of oral vitamin/mineral supplements [including thosethat contain vitamin K when not taken for therapeutic purposes] and paracetamol),unless in the opinion of the Principal Investigator and the Medical Monitor themedication will not interfere with the study procedures or compromise safety.

7. The subject is currently participating in a clinical study, e.g. attending follow-upvisits or has been administered an investigational drug (new chemical or biologicalentity) within 1 month (for small molecules) or 3 months (for biologicals) prior toadministration of the study drug.

8. The subject has donated ≥500 mL blood, plasma, or platelets in the 3 months prior toScreening or any other blood amount within 30 days prior to Screening.

9. Because of an increased risk of thrombosis subjects with known diabetes mellitus ora fasted glucose ≥7.0 mmol/L at Screening.

10. The subject has any bleeding diathesis, any increased risk of bleeding or, in theopinion of the Principal Investigator, is at increased risk of the consequences ofbleeding including but not limited to the following:

11. gastro-intestinal ulceration within the last 3 months;

12. known or suspected oesophageal varices;

13. vascular aneurysms or known arteriovenous malformations;

14. history of known major intraspinal or intracerebral vascular abnormalities;

15. history of brain, spinal or ophthalmic surgery within the last year;

16. any intracranial hemorrhage;

17. uncontrolled severe hypertension.

18. The subject has, in the opinion of the Principal Investigator, any increased risk ofthrombosis or thromboembolism including any known thrombophilia, such asantiphospholipid syndrome, or any past history of provoked or unprovoked arterial orvenous thrombosis, including thromboembolism.

19. The subject has a significant history of drug allergy, as determined by thePrincipal Investigator.

20. The subject has at Screening or on Day -1, a supine blood pressure or supine pulserate ≥ 150/95 mmHg and >100 beats per minute (bpm), respectively, or < 90/40 mmHgand 40 bpm, respectively, confirmed by a repeat assessment.

21. For Part 1, the subject consumes >21 alcoholic drinks/week for men or >14 alcoholicdrinks/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 significanthistory of alcoholism or drug/chemical abuse, as determined by the PrincipalInvestigator. For Part 2, the subject consumes >14 alcoholic drinks/week or has asignificant history of alcoholism or drug/chemical abuse, as determined by thePrincipal Investigator.

22. The subject has a positive drug screen, alcohol test or cotinine test result atScreening or on Day -1, confirmed by repeat testing.

23. The female subject has a positive pregnancy test at Screening or on Day -1 or islactating.

24. The subject currently smokes or uses nicotine-containing products. Former smokerswill be eligible, provided they have not smoked for at least 1 month prior toadministration of the study drug.

25. 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 thePrincipal Investigator.

26. The subject has a positive Hepatitis B surface antigen (HBsAg), Hepatitis Cantibody, or human immunodeficiency virus (HIV) antibody test result at Screening.

27. The subject has an abnormality in the 12-lead ECG at Screening or on Day -1 that, inthe judgement of the Principal Investigator may, during the study, interfere withthe interpretation of 12-lead ECG results, including average QTcF interval >450 msecfor men or >470 msec for women, 2nd or 3rd degree atrioventricular block, completeleft bundle branch block, complete right bundle branch block orWolff-Parkinson-White Syndrome, defined as average PR<110 msec, confirmed by atriplicate repeat ECG.

28. The subject has any other condition that, in the opinion of the PrincipalInvestigator, would compromise the safety of the subject or the subject's ability tocomply with the protocol and complete the study.

29. The subject has renal insufficiency (serum creatinine level > 1.25 times upper limitof normal (ULN) or estimated glomerular filtration rate (eGFR) of <60mL/min*1.73m2).

30. The subject has active liver disease (alanine aminotransferase [ALT] or aspartateaminotransferase [AST] >1.5x ULN, or total bilirubin > 1.5x ULN at Screening or onDay -1. One re-test is allowed).

31. The subject has previously participated in a clinical study with VMX-C001. Additional exclusion criteria for Part 2 only:

32. Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives orhas 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 30days prior to first administration of FXa DOAC.

33. Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives orhas received treatment with CYP3A4 inducers (e.g., St. John's wort, rifampicin,phenytoin, carbamazepine, phenobarbital) within 30 days prior to firstadministration of FXa DOAC.

34. Because of an effect on FXa DOACs, subjects are to be excluded if he/she receives orhas received treatment with selective serotonin reuptake inhibitors (SSRIs) orselective noradrenaline reuptake inhibitors (SNRIs) within 30 days prior to firstadministration of FXa DOAC.

35. The subject has any contra-indication to treatment with FXa DOACs.