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

NCT03651947 | Completed Phase 1

• 1 other identifier: QL1206-001
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy People

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Adverse events(AE)

  134 day

• serum CTX1

  134 day

Study Arms (2)

QL1206

EXPERIMENTAL

QL1206 injection (120mg) by subcutaneous injection once on the first day.

Drug: QL1206

Xgeva®

ACTIVE COMPARATOR

Xgeva® injection (120mg) by subcutaneous injection once on the first day.

Drug: Xgeva®

Interventions

QL1206 DRUG

subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

QL1206

Xgeva® DRUG

subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

Also known as: Denosumab Injection

Xgeva®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Interventions

QL1206; Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• yanhua DING, Professor

  The First Affiliated Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 29, 2018
• Study Start: August 20, 2018
• Primary Completion: November 17, 2018
• Study Completion: May 22, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

CN (1)