Healthy PeoplePhase 1NCT04213105
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
A Phase 1 study testing QL1206 and Prolia® in people with Healthy People, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- QL1206 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2019to 31 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jilin University
Changchun, Jilin, 130000
yanhua DING, Professor, dingyanhua2003@126.com
yanhua Ding, Professor
About this study
Official title: A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults
Read the detailed 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.
- Conditions
- Healthy People
- Being tested
- QL1206, Prolia®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1206Drug
subcutaneous injection of 60 mg (1ml) only once,on the first day.
Prolia®Drug
Also called Denosumab Injection
subcutaneous injection of 60 mg (1ml)only once,on the first day
| Study group | Role | What they receive |
|---|---|---|
| QL1206 | Experimental | QL1206 injection (60mg) by subcutaneous injection once on the first day Receives: Drug: QL1206 |
| Prolia® | Active comparator | Prolia® injection (120mg) by subcutaneous injection once on the first day Receives: Drug: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 134 day
Secondary outcomes (2)
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.
Measured: 134 day
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
Measured: 134 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start31 Oct 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized、double-blind、parallel-group、positive control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yanhua DING, Professor, Principal investigator, The First Affiliated Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213105
- Sponsor's protocol ID
- QL1206-002
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
- ClinicalTrials.gov ID
- NCT04213105
- Acronym / sponsor ID
- QL1206-002
- Conditions
- Healthy People
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized、double-blind、parallel-group、positive control
| Arm | Type | Receives |
|---|---|---|
| QL1206 | Experimental | Drug: QL1206QL1206 injection (60mg) by subcutaneous injection once on the first day |
| Prolia® | Active comparator | Drug: Prolia®Prolia® injection (120mg) by subcutaneous injection once on the first day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1206subcutaneous injection of 60 mg (1ml) only once,on the first day. | Drug | QL1206 |
| Prolia®Also: Denosumab Injectionsubcutaneous injection of 60 mg (1ml)only once,on the first day | Drug | Prolia® |
Primary outcome
Area under the plasma concentration-time curve (AUC0-t )
Time frame: 134 day
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t.
maximum plasma concentration(Cmax)
Time frame: 134 day
the maximum plasma concentration of QL1206/Prolia from 0 o'clock to the last measurable concentration acquisition time t.
2 secondary outcomes
Adverse events(AE)
Time frame: 134 day
serum CTX1
Time frame: 134 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yanhua DING, Professor principal investigator
The First Affiliated Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL1206 and Prolia® in people with Healthy People, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shunjiang yu, CMO (0531-83129659, shunjiang.yu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC0-t ) (time frame: 134 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.