TumorPhase 1NCT06232902
A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
A Phase 1 study testing QL1101 and Avastin® 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 QL1101 with EU-Avastin® in healthy male volunteers. Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 groups. 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?
- QL1101 and Avastin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 18 Nov 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
- Subjects who voluntarily sign the written ICF;
- Males aged 18- 50 years(inclusive).
- Body weight between 50.0 kg and 90.0 kg (inclusive), body mass index (BMI) between 18.0 kg/m2 and 28.0 kg/m2 (inclusive);
- Subjects who agree to practice effective contraception (including but not limited to physical contraception, surgery, or abstinence) throughout the study period until at least 6 months after study drug administration; See Appendix 3 for details;
- Subjects with no disease history or with a previous medical history which is not clinically significant or has no influence on the study as determined by the study doctor.
Who cannot join
- Subjects who have previously suffered or are currently suffering from any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, haematology, immunology and metabolic abnormalities or any other diseases that can interfere with the test results;
- Abnormalities in clinical laboratory tests, preoperative infectious markers, Chest X-ray, 12-lead ECG, physical examination, vital signs, Abdominal ultrasound were clinically significant or judged to have an impact on the study (based on the judgment of the clinical study doctor);
- History of hereditary bleeding, thrombophilia, thrombosis (eg, cerebral thrombosis, arteriovenous thrombosis), or history of non-traumatic bleeding and appropriate treatment, or any other condition that may predispose the subject to increased risk of bleeding or thrombosis (eg, thrombocytopenia, or INR > 1.5, etc.);
- Hypersensitivity to the investigational products or any component of the investigational products, history of specific allergy (Recurrent asthma, urticaria, eczema, etc.) or allergic constitution (such as two or more drugs, food such as milk and pollen allergy);
- Subjects with a history of gastrointestinal perforation, gastrointestinal fistula or any fistula or inflammatory bowel disease;
- Recent infection requiring systemic anti-infective treatment within 28 days or serious infection (hospitalization and/or requiring intravenous antibiotics) within 6 months before administration of investigational product;
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- Subjects who have received surgical operation or bone fracture within 4 weeks before screening, or plan to receive surgical operation during the study;
- One of the HBsAg, hepatitis C antibody, HIV antibody or Treponema pallidum antibody were tested positive;
- Subjects who have taken any medicine or healthcare product (including Chinese herbal medicine) within 14 days before administration of investigational product;
- Subjects who have received any biological products or live virus vaccines within 3 months or monoclonal antibodies within 9 months before the study treatment, or bevacizumab or VEGF targeted agents (such as aflibercept, ranibizumab, Conbercept, etc.) before administration of investigational product;
- Subjects who have participated in the clinical study and administered the investigational product within 3 months before administration of investigational product;
- Blood donors within 3 months before administration of investigational product;
- Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day;
- Subjects who are addicted to smoking or smoke more than 5 cigarettes per day in the 3 months before screening;
- Alcoholics or regular drinkers within 6 months before screening, defined as drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Drug abusers or those who have used soft drugs (such as marijuana) 3 months before screening or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before screening;
- Urine drug screening and breath test for alcohol was tested positive before administration of investigational product;
- Subjects who may not be able to complete this study for other reasons or should not be included in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Jilin University
Changchun, Jilin, 130000
About this study
Official title: A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers.
Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 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 QL1101 or EU-Avastin® in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.
Subjects would receive a single 100mg（4ml） of QL1101or EU-Avastin® injection.
- Conditions
- Tumor
- Being tested
- QL1101, Avastin®
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1101Drug
3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day
Avastin®Drug
3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day
| Study group | Role | What they receive |
|---|---|---|
| QL1101 | Experimental | QL1101, intravenous infusion 90 min (±5min), D1 (Day 1, single dose) Receives: Drug: QL1101 |
| Avastin® | Active comparator | Avastin®, intravenous infusion 90 min (±5min), D1 (Day 1, single dose) Receives: Drug: Avastin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single intravenous infusion in healthy volunteers
Measured: 99 day
Cmax
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single
Measured: 99 day
Secondary outcomes (8)
AUC0-t
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Measured: 99 day
Tmax
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Measured: 99 day
t1/2
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Measured: 99 day
CL
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Measured: 99 day
Vd
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Measured: 99 day
(AUC0--∞ -AUC0-t)/（AUC0--∞×100%)
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Measured: 99 day
the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0
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;
Measured: 99 day
immunogenicity
Immunogenicity will be assessed by the incidence of ADA and Nab.
Measured: 99 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start20 Jun 2024
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
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
- 84 participants (actual)
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
- NCT06232902
- Sponsor's protocol ID
- QL1101-102
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2024
- Last updated
- 18 Dec 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06232902
- Acronym / sponsor ID
- QL1101-102
- Conditions
- Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 31 Jan 2024 (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 QL1101 with EU-Avastin® in healthy male volunteers.
Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 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 QL1101 or EU-Avastin® in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.
Subjects would receive a single 100mg（4ml） of QL1101or EU-Avastin® injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1101 | Experimental | Drug: QL1101QL1101, intravenous infusion 90 min (±5min), D1 (Day 1, single dose) |
| Avastin® | Active comparator | Drug: Avastin®Avastin®, intravenous infusion 90 min (±5min), 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)
- Subjects who voluntarily sign the written ICF;
- Males aged 18- 50 years(inclusive).
- Body weight between 50.0 kg and 90.0 kg (inclusive), body mass index (BMI) between 18.0 kg/m2 and 28.0 kg/m2 (inclusive);
- Subjects who agree to practice effective contraception (including but not limited to physical contraception, surgery, or abstinence) throughout the study period until at least 6 months after study drug administration; See Appendix 3 for details;
- Subjects with no disease history or with a previous medical history which is not clinically significant or has no influence on the study as determined by the study doctor.
Key exclusion criteria (18 listed)
- Subjects who have previously suffered or are currently suffering from any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, haematology, immunology and metabolic abnormalities or any other diseases that can interfere with the test results;
- Abnormalities in clinical laboratory tests, preoperative infectious markers, Chest X-ray, 12-lead ECG, physical examination, vital signs, Abdominal ultrasound were clinically significant or judged to have an impact on the study (based on the judgment of the clinical study doctor);
- History of hereditary bleeding, thrombophilia, thrombosis (eg, cerebral thrombosis, arteriovenous thrombosis), or history of non-traumatic bleeding and appropriate treatment, or any other condition that may predispose the subject to increased risk of bleeding or thrombosis (eg, thrombocytopenia, or INR > 1.5, etc.);
- Hypersensitivity to the investigational products or any component of the investigational products, history of specific allergy (Recurrent asthma, urticaria, eczema, etc.) or allergic constitution (such as two or more drugs, food such as milk and pollen allergy);
- Subjects with a history of gastrointestinal perforation, gastrointestinal fistula or any fistula or inflammatory bowel disease;
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 |
|---|---|---|
| QL11013mg/kg, single intravenous infusion over 90 min (± 5 min) on first day | Drug | QL1101 |
| Avastin®3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day | Drug | Avastin® |
Primary outcome
AUC0-∞
Time frame: 99 day
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single intravenous infusion in healthy volunteers
Cmax
Time frame: 99 day
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single
8 secondary outcomes
AUC0-t
Time frame: 99 day
Tmax
Time frame: 99 day
t1/2
Time frame: 99 day
CL
Time frame: 99 day
Vd
Time frame: 99 day
(AUC0--∞ -AUC0-t)/（AUC0--∞×100%)
Time frame: 99 day
the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0
Time frame: 99 day
immunogenicity
Time frame: 99 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 QL1101 and Avastin® 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 18 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: finished, as of the sponsor's last update on 18 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞ (time frame: 99 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 18 Dec 2024.