Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
Study Details
Study Description
Brief Summary
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This is a phase I,single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of QL1206 or Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Prolia® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarities of QL1206 or Prolia® preliminarily. Subjects would receive a single 60mg（1ml） of QL1206 or through subcutaneous injection.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QL1206 QL1206 injection (60mg) by subcutaneous injection once on the first day |
Drug: QL1206
subcutaneous injection of 60 mg (1ml) only once,on the first day.
|
| Active Comparator: Prolia® Prolia® injection (120mg) by subcutaneous injection once on the first day |
Drug: Prolia®
subcutaneous injection of 60 mg (1ml)only once,on the first day
Other Names:
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Outcome Measures
Primary Outcome Measures
- Area under the plasma concentration-time curve (AUC0-t ) [134 day]
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t.
- maximum plasma concentration(Cmax) [134 day]
the maximum plasma concentration of QL1206/Prolia from 0 o'clock to the last measurable concentration acquisition time t.
Secondary Outcome Measures
- Adverse events(AE) [134 day]
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
- serum CTX1 [134 day]
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis. the secondary outcome measures the percent change in serum CTX1 throughout the study from baseline to 134 day
Eligibility Criteria
Criteria
Inclusion Criteria:
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Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
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Aged ≥18 years or ≤50 years, male or female (including the boundary value);
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Agree to take effective contraceptive measures throughout the study period (including not limited to: hormonal drugs of pregnancy, physical contraception, surgery, abstinence, etc., until at least 6 months after the last study is administered;
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Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance
Exclusion Criteria:
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Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
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Serum calcium levels are outside the normal range of the laboratory, or the subject uses calcium supplements in the screening period.
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The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
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Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Jilin University | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: yanhua DING, Professor, The First Affiliated Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL1206-002