A Study to Compare the Pharmacokinetic Similarity of JHL1266 versus Prolia in Healthy Subjects
- Conditions
- OsteoporosisMusculoskeletal - Osteoporosis
- Registration Number
- ACTRN12620000013965
- Lead Sponsor
- JHL Biotech Australia Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 225
1. Willing and able to understand and sign an informed consent inform (ICF);
2. Male age between 25 to 55 years (inclusive); female age between 25 to 45 years (inclusive)
3. Healthy subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests);
4. Body Mass Index (BMI) between 18.0 and 32.0 kg per sq mtr (inclusive) ;
5. Weight between 50 to 100 kg (inclusive);
6. Men and women of childbearing age who have not undergone sterilization surgery must agree to practice effective contraception during the treatment period and within 5 months after the last administration of the study drug;
7. Do not smoke or smoke fewer than 5 cigarettes daily within 3 months prior to screening; do not drink or drink less than 14 units of alcohol within 6 months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine).
8. Able to abstain from caffeine and for the duration of confinement.
1. Prior diagnosis of bone disease, or any condition that will affect bone metabolism;
2. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures, poor oral hygiene, periodontal, and/or pre-existing dental disease;
3. Past history of skin cancer;
4. History of recurrent skin infections or skin conditions;
5. Recent tooth extraction (within 6 months of screening visit);
6. Evidence of hypocalcaemia at screening;
7. Known vitamin D deficiency; or known intolerance to calcium or vitamin D supplements;
8. Any history of clinically serious diseases such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases;
9. Previous exposure to any monoclonal antibody or current use of any biologics for a medical condition or in the context of another clinical trial in the 6 months or 5 half-lives (whichever is longer) prior to screening;
10. History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients;
11. Use of prescription or non-prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking study drug (whichever is longer), and for the duration of the study until the final follow-up visit. Herbal supplements must be discontinued 14 days prior to the administration of study drug;
12. Prior use of medications used for the treatment or prevention of osteoporosis or medication affecting bone turnover;
13. History of a blood donation within 3 months prior to the administration of study drug;
14. Have participated in any other clinical study within 3 months or 5 half-lives prior to the administration of study drug;
15. Have positive test results for hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies;
16. Women with a positive pregnancy test at screening or Day -1 or planning to become pregnant or lactating;
17. Have a history of drug abuse;
18. Unlikely to comply with the protocol requirements, instructions, and study related restrictions;
19. Subject has the presence of tattoos, sunburn, or other skin disturbances on both the left and right upper arm which may interfere with a medical assessment of the injection site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method