| Eligibility |
Inclusion Criteria:
1. Healthy males and females, 18 to 59 years (inclusive) at screening.
2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
3. Body mass weight between 50 and 110 kg (inclusive)
4. Medical history, vital signs, physical examination, standard 12-lead electrocardiogram
(ECG) and laboratory investigations must be clinically acceptable or within laboratory
reference ranges for the relevant laboratory tests, unless the investigator considers
the deviation to be irrelevant for the purpose of the study.
5. Non-smokers or past-smokers who stopped at least 3 months before the study.
6. Female subject must be either of
- non-childbearing potential: post-menopausal (defined as at least 1 year without
any menses) prior to Screening, or documented surgically sterile or status post
hysterectomy (at least 1 month prior to Screening).
- or, if of childbearing potential, must have a negative serum pregnancy test at
Screening and must use two forms of birth control (at least one of which must be
a barrier method) starting at Screening and throughout the study period and for
28 days [or 5 half-lives of the study drug whichever is longer] after the final
study drug administration. Acceptable forms of birth control include: placement
of a non-hormonal intrauterine device or intrauterine system, 2) barrier methods
of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) or
abstinence of male/female intercourse if it is a part of normal practice in her
life.
The use of hormonal contraception in this study is not allowed. For male subjects
contraception is not needed during this study.
7. Injection sites must be clear of tattoos, scars and moles.
8. Signed written consent given for participation in the study.
Exclusion Criteria:
1. Any history or evidence of any clinically significant cardiovascular,
gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,
urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major
disease, as judged by the Investigator.
2. Medical history of malignant disease (with the exception of localized skin or cervical
carcinoma that had been excised and cured)
3. Any clinically significant abnormality following the Investigator's review of the
physical examination, ECG and clinical study protocol-defined clinical laboratory
tests at screening or admission to the clinical unit.
4. A pulse < 40 or > 100 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic
blood pressure > 90 mmHg (measurements taken in triplicate after subject has been
resting in supine position for 5 minutes.
5. A mean corrected QT interval using Fridericia's formula (QTcF) interval > 450 ms at
screening. If the mean QTcF exceeds the limits above, one additional triplicate ECG
may be taken. If this triplicate also gives an abnormal result, the subject should be
excluded.
6. History of smoking within 3 months prior to the first admission to the clinical unit.
7. History of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol
= 250 ml of beer [5%] or 35 ml of spirits [35%] or 100 ml of wine [12%]) within 3
months prior to the first admission to the clinical unit.
8. Any recreational use of drugs-of-abuse within 3 months prior to the first
administration of an IMP.
9. Use of any prescribed or non-prescribed drugs (including vitamins, natural and herbal
remedies, e.g., St. John's Wort) in the 2 weeks prior to first study medication
administration, except for the occasional use of paracetamol (up to 2 g/day)- except
if it will not affect the study outcome at the discretion of the investigator.
10. Use of drugs that induce hepatic enzymes (rifampicin, rifabutin, carbamazepine,
phenobarbitone, phenytoin, primidone, and aminoglutethimide).
11. Use of inhibitors of the CYP3A4 enzyme (including but not only clarithromycin,
itraconazole, erythromycin, fluconazole, verapamil).
(https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-intera
ctions-table-substrates-inhibitors-and-inducers)
12. Participation in any clinical study within 3 months prior to the expected date of
enrolment into the clinical study, provided that the clinical study did not entail a
biological compound with a long half-life or participation in more than 3 clinical
studies within 12 months.
13. Treatment within the previous 3 months before the first administration of IMP with any
drug with a well-defined potential for adversely affecting a major organ or system.
14. A major illness during the 3 months before commencement of the screening period.
15. Relevant history or laboratory or clinical findings indicative of acute or chronic
disease, likely to influence study outcome.
16. Any significant blood loss, donated one unit (450 m) of blood or more, or received a
transfusion of any blood or blood products within 60 days, or donated plasma within 7
days prior to the first admission to the clinical unit.
17. History of hypersensitivity or allergy to the IMP or its excipients or any related
medication.
18. The subject has any other condition, which in the opinion of the Investigator
precludes the subject's participation in the clinical study, including any conditions
mentioned in contraindication, special warnings and precautions for use, in the
summary of product characteristics of the IMP.
19. History of COVID illness in last 30 days.
20. Positive serology test for hepatitis B surface antigen, hepatitis C virus antibodies
or human immunodeficiency virus-1 and/or 2 antibodies.
21. Positive pregnancy test.
22. Positive urine screen for drugs of abuse. In case of a positive result the urine
screen for drugs of abuse may be repeated once at the discretion of the investigator.
23. Positive urine screen for tobacco use.
24. Any specific investigational product safety concern.
25. Vulnerable subjects, e.g. persons in detention.
26. Employee of the sponsor (or authorized representative), or FARMOVS (or authorized
representative)
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