TumorPhase 1NCT06173011
A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Adults
A Phase 1 study testing QL2107, Keytruda®(china) and Keytruda®(US) in people with Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tumor
- What is being tested?
- QL2107, Keytruda®(china) and Keytruda®(US)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to Jul 2024
- 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
- Men only
- 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;
- Age 18 ~ 50 (inclusive) years , male;
- 50.0 kg≤ body weight ≤90.0 kg and 18.0 kg/m2≤ Body mass index (BMI) ≤28.0 kg/m2;
- Agree to use effective contraception throughout the study period (including but not limited to: physical contraception, surgery, abstinence, etc.) until at least 6 months after the study dosing;
- No history of disease or abnormal past medical history is not clinically significant, and the study doctor's judgment has no impact on the trial.
Who cannot join
- 1. Clinical laboratory examination, infectious disease screening, chest orthogram examination, abdominal color ultrasound examination, 12-lead electrocardiogram, heart color ultrasound, physical examination, vital signs (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg) the abnormalities in each examination have clinical significance or are determined to have an impact on the trial (subject to the judgment of the clinical study physician);
- Have been or are currently suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that can interfere with the test results;
- 3. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: rheumatoid arthritis, ankylosing spondylitis, autoimmune hemolytic anemia, interstitial pneumonia, uveitis, inflammatory bowel disease, autoimmune hepatitis, autoimmune pituitaritis, glomerulonephritis, hyperthyroidism or hypothyroidism, etc.)
- 4. Known history of tuberculosis or suspected clinical manifestations of tuberculosis (including but not limited to tuberculosis, lymphatic tuberculosis, tuberculous pleurisy, etc.);
- 5. Patients with a history of acute infection within 2 weeks before screening;
- 6. There have been herpes zoster virus infections within 3 months before screening;
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- 7. Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody screening positive;
- 8. Allergies (multiple drug and food allergies), who were determined by the researcher to be unable to participate in this study;
- 9. Patients who had surgery within 4 weeks prior to screening or planned to have surgery during the study period;
- 10. Those who have used any biological product or received live viral vaccine (tetanus toxoid vaccine within 1 year before infusion), used any monoclonal antibody within 6 months or 5 biological half-lives of drug metabolism, or used PD-1/PD-L1 drugs in the past;
- 11. Those who have used any drug or health product (including Chinese herbal medicine) within 14 days prior to the infusion of the experimental drug;
- 12. Participants who participated in any clinical trial and used any clinical trial drug within 3 months prior to screening;
- 13. Study patients who donated blood or lost a large amount of blood (> 400 mL) or received blood transfusions or used blood products within 3 months prior to administration;
- 14. Smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to screening or who could not stop using any tobacco products during the trial;
- 15. Positive drug screening or/and alcohol breath test screening prior to study administration;
- 16. A history of drug and/or alcohol abuse (14 units of alcohol consumed per week "1 unit = 285 mL for beer, 25 mL for spirits, or 100 mL for wine");
- 17. Subjects who have other factors deemed unsuitable for the study by the investigator;
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, Single-dose, Parallel Three-group Study to Compare the Pharmacokinetics and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Male Adults
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers.
Participants will receive a single injection of QL2107/ Keytruda® （China）/Keytruda® （US）.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the three groups.
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 injections of QL2107 or Keytruda® （China/US） in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2107 or Keytruda® （China/US） in healthy volunteers.
Subjects would receive a single 100mg（4ml） of QL2107or Keytruda® （China/US）injection.
- Conditions
- Tumor
- Being tested
- QL2107, Keytruda®(china), Keytruda®(US)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2107Drug
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
Keytruda®(china)Drug
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
Keytruda®(US)Drug
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
| Study group | Role | What they receive |
|---|---|---|
| QL2107 | Experimental | QL2107, intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose) Receives: Drug: QL2107 |
| Keytruda®(china) | Active comparator | Keytruda® (china), intravenously infusion 35 min (±5min, at least 30min), D1 (Day 1, single dose); Receives: Drug: Keytruda®(china) |
| Keytruda®(US) | Active comparator | Keytruda® (US), intravenously infusion 35 min (±5min, at least 30min), D1 (Day 1, single dose); Receives: Drug: Keytruda®(US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
To evaluate pharmacokinetic similarity between QL2107 and Keytruda® (china/US)after a single intravenous infusion in healthy volunteers
Measured: 113day
Secondary outcomes (8)
safety and immunogenicity
Safety, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.after a single intravenous infusion in healthy volunteers;Immunogenicity will be assessed by the incidence of ADA and Nab.
Measured: 113day
Cmax
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
Tmax
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
AUC0-t
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
t1/2
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
CL
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
Vd
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
AUC_%Extrap
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Measured: 113day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start12 Dec 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173011
- Sponsor's protocol ID
- QL2107-101
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Parallel Three-group Study to Compare the Pharmacokinetics and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT06173011
- Acronym / sponsor ID
- QL2107-101
- Conditions
- Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers.
Participants will receive a single injection of QL2107/ Keytruda® （China）/Keytruda® （US）.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the three groups.
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 injections of QL2107 or Keytruda® （China/US） in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2107 or Keytruda® （China/US） in healthy volunteers.
Subjects would receive a single 100mg（4ml） of QL2107or Keytruda® （China/US）injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QL2107 | Experimental | Drug: QL2107QL2107, intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose) |
| Keytruda®(china) | Active comparator | Drug: Keytruda®(china)Keytruda® (china), intravenously infusion 35 min (±5min, at least 30min), D1 (Day 1, single dose); |
| Keytruda®(US) | Active comparator | Drug: Keytruda®(US)Keytruda® (US), intravenously infusion 35 min (±5min, at least 30min), D1 (Day 1, single dose); |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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;
- Age 18 ~ 50 (inclusive) years , male;
- 50.0 kg≤ body weight ≤90.0 kg and 18.0 kg/m2≤ Body mass index (BMI) ≤28.0 kg/m2;
- Agree to use effective contraception throughout the study period (including but not limited to: physical contraception, surgery, abstinence, etc.) until at least 6 months after the study dosing;
- No history of disease or abnormal past medical history is not clinically significant, and the study doctor's judgment has no impact on the trial.
Key exclusion criteria (17 listed)
- 1. Clinical laboratory examination, infectious disease screening, chest orthogram examination, abdominal color ultrasound examination, 12-lead electrocardiogram, heart color ultrasound, physical examination, vital signs (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg) the abnormalities in each examination have clinical significance or are determined to have an impact on the trial (subject to the judgment of the clinical study physician);
- Have been or are currently suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that can interfere with the test results;
- 3. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: rheumatoid arthritis, ankylosing spondylitis, autoimmune hemolytic anemia, interstitial pneumonia, uveitis, inflammatory bowel disease, autoimmune hepatitis, autoimmune pituitaritis, glomerulonephritis, hyperthyroidism or hypothyroidism, etc.)
- 4. Known history of tuberculosis or suspected clinical manifestations of tuberculosis (including but not limited to tuberculosis, lymphatic tuberculosis, tuberculous pleurisy, etc.);
- 5. Patients with a history of acute infection within 2 weeks before screening;
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 |
|---|---|---|
| QL2107intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose) | Drug | QL2107 |
| Keytruda®(china)intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose) | Drug | Keytruda®(china) |
| Keytruda®(US)intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose) | Drug | Keytruda®(US) |
Primary outcome
AUC0-∞
Time frame: 113day
To evaluate pharmacokinetic similarity between QL2107 and Keytruda® (china/US)after a single intravenous infusion in healthy volunteers
8 secondary outcomes
safety and immunogenicity
Time frame: 113day
Cmax
Time frame: 113day
Tmax
Time frame: 113day
AUC0-t
Time frame: 113day
t1/2
Time frame: 113day
CL
Time frame: 113day
Vd
Time frame: 113day
AUC_%Extrap
Time frame: 113day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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.
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 QL2107, Keytruda®(china) and Keytruda®(US) in people with Tumor, 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 5 inclusion and 17 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 23 Jan 2024. 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 yanhua ding (0431-88782168, dingyanhua2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞ (time frame: 113day). 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 23 Jan 2024.