| Eligibility |
Inclusion Criteria:
1. The subject is a male of any race, between 28 and 55 years of age, inclusive, at
screening.
2. The subject has a BMI between 18.5 and 29.9 kg/m2, inclusive, (total body weight
between 60 and 95 kg, inclusive) at screening and check-in.
3. The subject is considered by the investigator to be in good general health as
determined by medical history, clinical laboratory test results (congenital
nonhaemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable), vital sign
measurements (systolic BP =90 mm Hg and =140 mm Hg, diastolic BP =50 mm Hg and =90 mm
Hg), 12 lead ECG results, and physical examination findings at screening and check in.
4. The subject must use an adequate method of contraception (eg, condom) or be willing to
practice sexual abstinence during the study starting from the day of dosing and for
140 days after dosing. The subject must agree to not donating sperm during the study
and for at least 140 days after dosing. Participating subject's female partner of
childbearing potential should use an additional form of contraception such as an intra
uterine device, barrier method with spermicide, oral contraceptive, injectable
progesterone, or sub-dermal implant starting from the male partner's day of dosing
until at least 140 days after dosing. The female partner of the participating subject
should be familiar with the use of the respective contraceptive methods. Intra-uterine
devices and hormonal methods for contraception should be used for at least 1
menstruation cycle prior to the administration of study drug.
5. The subject must be able to comprehend and willing to sign an ICF and to abide by the
study restrictions. Subjects must have signed an ICF before any study-related
procedure or evaluation is performed.
Exclusion Criteria:
1. The subject has had previous exposure to denosumab.
2. The subject has a significant history or clinical manifestation of any metabolic,
allergic, dermatological, hepatic, renal, haematological, cardiovascular,
gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as
determined by the investigator.
3. The subject has a history of significant hypersensitivity, intolerance, or allergy to
any drug compound, food, or other substance, unless approved by the investigator.
4. The subject has any current or recent history of infections, including localised
infections (within 2 months prior to screening for any serious infection that requires
hospitalisation or IV anti-infective or within 14 days prior to screening for any
active infection which requires oral treatment).
5. The subject has a dental or jaw disease requiring oral surgery or dental surgery
within 6 months prior to study product administration or plans to have dental surgery
within 6 months after dosing.
6. The subject has a history of osteomyelitis or osteonecrosis of the jaw requiring
suturing within 30 days before dosing, or within 30 days after the last study visit.
7. The subject has a medically significant dental disease or dental neglect, with signs
and/or symptoms of local or systemic infection that would likely require a dental
procedure during the course of the study. Standard dentistry treatments (eg, dental
filling or prophylaxis/cleaning) are allowed.
8. The subject has clinically relevant history of alcoholism, addiction or drug/chemical
abuse prior to check in, and/or positive urinary test for alcohol or drugs of abuse at
screening or check in.
9. The subject has positive hepatitis panel (HBV and HCV) or positive HIV test. Subjects
whose results are compatible with prior immunisation and not infection may be included
at the discretion of the investigator.
10. The subject has participated in a clinical study involving administration of an
investigational drug (new chemical entity), with dosing in the past 90 days prior to
Day 1, or within 5 half-lives of the investigational drug used in the study, whichever
is longer.
11. The subject has used or intends to use slow-release medications/products considered to
still be active within 30 days prior to check in, unless deemed acceptable by the
investigator.
12. The subject has used or intends to use any nonprescription medications/products
(except paracetamol [up to 2 g/day] and ibuprofen [800 mg/day]), including vitamins,
minerals, supplements (eg, Biotin), and phytotherapeutic/herbal/plant-derived
preparations within 7 days prior to check in, unless deemed acceptable by the
investigator. Vitamin C, vitamin D, and calcium in daily recommended doses (=1000 mg
elemental calcium and 1000 IU vitamin D based on screening levels of vitamin D) are
allowed.
13. The subject has received the COVID-19 vaccine within 14 days before Day 1 or plans to
receive a COVID-19 vaccine within 12 weeks after study drug dosing or has positive
test for COVID 19 during screening or presence of COVID 19 symptoms within 4 weeks
prior to Day -1.
14. The subject has received a live or attenuated vaccine within 3 months prior to
screening or has the intention to receive a vaccine during the study. The subject
intends to travel to a region where a vaccination will be required due to endemic
disease during the study.
15. The subject has used tobacco- or nicotine-containing products within 1 year prior to
check-in or anytime during the study, or has a positive cotinine test upon screening
or check-in.
16. The subject has donated blood within 60 days prior to dosing, plasma from 14 days
prior to screening, or platelets from 42 days prior to dosing.
17. The subject has poor peripheral venous access.
18. Subjects who, in the opinion of the investigator, should not participate in this
study.
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