Clinical trial NCT04213105: Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
Official title: A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy People
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized、double-blind、parallel-group、positive control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC0-t )
timeFrame: 134 day
measure: maximum plasma concentration(Cmax)
timeFrame: 134 day
Secondary outcomes:
measure: Adverse events(AE)
timeFrame: 134 day
measure: serum CTX1
timeFrame: 134 day
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Affiliated Hospital of Jilin University
name: yanhua DING, Professor
role: PRINCIPAL_INVESTIGATOR
References: