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

Healthy People Clinical Trial

Official title:

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213105
• Other study ID #: QL1206-002
• Status: Recruiting
• Phase: Phase 1
• Start date: October 31, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: December 2019
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: shunjiang yu, CMO
• Phone: 0531-83129659
• Email: shunjiang.yu[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy People

Intervention

Drug:
• QL1206
subcutaneous injection of 60 mg (1ml) only once,on the first day.
• Prolia®
subcutaneous injection of 60 mg (1ml)only once,on the first day

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC0-t )	Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t.	134 day
Primary	maximum plasma concentration(Cmax)	the maximum plasma concentration of QL1206/Prolia from 0 o'clock to the last measurable concentration acquisition time t.	134 day
Secondary	Adverse events(AE)	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.	134 day
Secondary	serum CTX1	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	134 day