MedDataX Logo

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

NCT ID: NCT04213105

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy People

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized、double-blind、parallel-group、positive control
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

QL1206

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

Group Type EXPERIMENTAL

QL1206

Intervention Type DRUG

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

Prolia®

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

Group Type ACTIVE_COMPARATOR

Prolia®

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QL1206

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

Intervention Type DRUG

Prolia®

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Denosumab Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

yanhua DING, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Jilin University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

shunjiang yu, CMO

Role: CONTACT

Phone: 0531-83129659

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

yanhua DING, Professor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QL1206-002

Identifier Type: -

Identifier Source: org_study_id