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

NCT04213105 | Unknown Phase 1

• 1 other identifier: QL1206-002
• Study Type: interventional
• Target: 144
• 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 Prolia® in healthy adults

Conditions

Healthy People

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Adverse events(AE)

  134 day

• serum CTX1

  134 day

Study Arms (2)

QL1206

EXPERIMENTAL

QL1206 injection (60mg) by subcutaneous injection once on the first day

Drug: QL1206

Prolia®

ACTIVE COMPARATOR

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

Drug: Prolia®

Interventions

QL1206 DRUG

subcutaneous injection of 60 mg (1ml) only once,on the first day.

QL1206

Prolia® DRUG

subcutaneous injection of 60 mg (1ml)only once,on the first day

Also known as: Denosumab Injection

Prolia®

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

RECRUITING

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

Central Study Contacts

shunjiang yu, CMO

CONTACT

0531-83129659; shunjiang.yu@qilu-pharma.com

Study Design

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

Model Details: randomized、double-blind、parallel-group、positive control

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 30, 2019
• Study Start: October 31, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

CN (1)