Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults

• Status: Recruiting
• Trial end date: 2020-10-31
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Treatments: Denosumab

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;