Healthy People
Conditions
Brief summary
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults
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.
Interventions
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized、double-blind、parallel-group、positive control
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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; * Aged ≥18 years or ≤50 years, male or female (including the boundary value); * 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; * 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
* Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously. * Serum calcium levels are outside the normal range of the laboratory, or the subject uses calcium supplements in the screening period. * 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; * Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary Contactshunjiang yu, CMO
Outcome results
None listed