| Eligibility |
Inclusion Criteria:
1. Willing and able to give written informed consent for participation in the study.
2. Healthy male subject aged 18-50 years inclusive at screening.
3. BMI = 18.0 and = 30.0 kg/m2 and weight at least 50 kg and no more than 100 kg at
screening.
4. Overtly healthy based on medical history, physical findings, vital signs, ECG and
laboratory values at the time of screening, as judged by the Investigator.
5. Male subjects must be willing to use condom or be vasectomised or practice sexual
abstinence to prevent pregnancy and drug exposure of a partner, and refrain from
donating sperm from the date of dosing until 3 months after (last) dosing with the
IMP. Their female partner of child-bearing potential are expected to use contraceptive
methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and
progestogen containing] hormonal contraception associated with inhibition of ovulation
[oral, intravaginal, transdermal], progestogen-only hormonal contraception associated
with inhibition of ovulation [oral, injectable, implantable], intrauterine device
[IUD] or intrauterine hormone-releasing system [IUS]).
Exclusion Criteria:
1. History of any clinically significant disease or disorder which, in the opinion of the
Investigator, may either put the subject at risk because of participation in the
study, or influence the results or the subject's ability to participate in the study.
2. Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of IMP.
3. Malignancy within the past 5 years with the exception of in situ removal of basal cell
carcinoma.
4. Any planned major surgery within the duration of the study.
5. Any positive result on screening for serum hepatitis B surface antigen (HbsAg),
hepatitis C antibody and Human Immunodeficiency Virus (HIV).
6. History of thromboembolic events.
7. History of significant bleeding (gross haematuria, haemoptysis, gastrointestinal tract
bleeding).
8. Evidence or history of a hypercoagulable state (e.g. shortened APTT).
9. Prior exposure to recombinant Annexin A5 (for diagnostic purposes).
10. Any history of coronary artery disease or cerebrovascular accident.
11. Known cardiac disease, cardiac anomaly or cardiac deformity.
12. Known heredity for autoimmune disease with described presence of potentially
pathogenic Annexin A5 antibodies, e.g. antiphospholipid syndrome, systemic lupus
erythematosus or systemic sclerosis, as judged by the Investigator.
13. Any history of or active peptic ulcer disease.
14. Any clinically significant disease affecting the respiratory tract (e.g. obstructive
and restrictive respiratory disease, chronic respiratory disease such as alveolitis,
inflammatory respiratory disease, autoimmune respiratory disease, present respiratory
infections, pulmonary vascular disease) that would influence the results of the study
or the subject's ability to participate in the study, as judged by the Investigator.
15. eGFR (based on plasma-creatinine) outside of normal range at screening or known renal
impairment (=70 mL/min).
16. Vaccination with live-attenuated vaccines within 4 weeks of the screening visit.
17. After 5 minutes supine rest at the time of screening, any vital signs values outside
the following ranges:
- Systolic blood pressure <90 or >140 mmHg, or
- Diastolic blood pressure <40 or >90 mmHg, or
- Pulse <40 or >100 bpm
18. Current evidence or history of bacterial, viral or fungal infections within 7 days
before (first) IMP administration as judged by the Investigator.
19. Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant
abnormalities in the resting ECG at the time of screening, as judged by the
Investigator.
20. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
judged by the Investigator, or history of hypersensitivity to drugs with a similar
chemical structure or class to ANXV.
21. Regular use of any prescribed or non-prescribed medication including antacids,
analgesics, herbal remedies, vitamins and minerals within two weeks prior to the
(first) administration of IMP, except occasional intake of paracetamol (maximum 2,000
mg/day; and not exceeding 3,000 mg/week), at the discretion of the Investigator and
nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum
of 10 days, at the discretion of the Investigator.
22. Planned treatment or treatment with another investigational drug within 3 months prior
to Day -1. Subjects consented and screened but not dosed in previous phase I studies
are not excluded.
23. Current smokers or users of nicotine products. Smokers that stopped smoking <3 months
prior to screening.
24. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit
prior to administration of the IMP.
25. History of alcohol abuse or excessive intake of alcohol, as judged by the
Investigator.
26. Presence or history of drug abuse, as judged by the Investigator.
27. History of, or current use of, anabolic steroids.
28. Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine
containing beverages.
29. Intake of xanthine and/or taurine containing energy drinks within 2 days prior to
screening.
30. Plasma donation within one month of screening or blood donation (or corresponding
blood loss) of >450 ml during the three months prior to screening.
31. Investigator considers the subject unlikely to comply with study procedures,
restrictions and requirements, or unfit for participation for any other reason.
32. Previous confirmed COVID-19 disease requiring hospital care or positive COVID-19 test
on admission to the clinic.
33. Insufficient venous access for study procedures.
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