Metastatic Colorectal CancerPhase 1NCT05110118
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
A Phase 1 study testing LY01008 and Avastin in people with Metastatic Colorectal Cancer and Non Small Cell Lung Cancer Metastatic, run by Shandong Boan Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
- What is being tested?
- LY01008 and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2020to 13 Jan 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Subjects aged 18 - 45 years
- Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg
- Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2
Who cannot join
- Subjects with evidence or history of clinically significant disease
- Subjects with a history of previous cancer
- Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg confirmed by a repeat measurement on the same day)
- Subjects with a history of blood donation 3 months before study drug infusion
- Subjects with a history of exposure to antibodies 12 months before study drug infusion
- Subjects with previous exposure to anti-VEGF therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single-dose, Parallel-group Study Comparing Pharmacokinetic Characteristics, Safety , Tolerability and Immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in Healthy Chinese Male Subjects
This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.
- Conditions
- Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
- Being tested
- LY01008, Avastin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY01008Drug
Also called Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection
Single intravenous injection
AvastinDrug
Also called Bevacizumab
Single intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| LY01008 | Experimental | Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min). Receives: Drug: LY01008 |
| Avastin | Active comparator | Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min). Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
Measured: From baseline to Day 99
Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
Measured: From baseline to Day 99
Maximum (peak) plasma concentration（Cmax）
Measured: From baseline to Day 99
Chloride（CL）
Measured: From baseline to Day 99
Terminal elimination half-life（t1/2）
Measured: From baseline to Day 99
Apparent volume of distribution（Vd）
Measured: From baseline to Day 99
Secondary outcomes (7)
Adverse Events(AEs)
Measured: From baseline to Day 99
Vital signs
Measured: From baseline to Day 99
Physical examinations
Measured: From baseline to Day 99
Clinical laboratory tests
Measured: From baseline to Day 99
12-lead ECGs
Measured: From baseline to Day 99
Positive rate of serum anti-drug antibody (ADA)
Measured: From baseline to Day 99
Positive rate of neutralizing antibody (NAb)
Measured: From baseline to Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start4 Aug 2020
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Boan Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110118
- Sponsor's protocol ID
- LY01008/CT-CHN-103
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin(R) in healthy Chinese male subjects. Expert Opin Biol Ther. 2022 Feb;22(2):263-269. doi: 10.1080/14712598.2022.2019703. Epub 2021 Dec 27.
PubMed 34913787
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Parallel-group Study Comparing Pharmacokinetic Characteristics, Safety , Tolerability and Immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05110118
- Acronym / sponsor ID
- LY01008/CT-CHN-103
- Conditions
- Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shandong Boan Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 5 Nov 2021 (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.
This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY01008 | Experimental | Drug: LY01008Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min). |
| Avastin | Active comparator | Drug: AvastinSingle intravenous injection of Avastin 3 mg/kg for 90 min(±1 min). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers
- Subjects aged 18 - 45 years
- Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg
- Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2
Key exclusion criteria (6 listed)
- Subjects with evidence or history of clinically significant disease
- Subjects with a history of previous cancer
- Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg confirmed by a repeat measurement on the same day)
- Subjects with a history of blood donation 3 months before study drug infusion
- Subjects with a history of exposure to antibodies 12 months before study drug infusion
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 |
|---|---|---|
| LY01008Also: Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody InjectionSingle intravenous injection | Drug | LY01008 |
| AvastinAlso: BevacizumabSingle intravenous injection | Drug | Avastin |
Primary outcome
Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
Time frame: From baseline to Day 99
Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
Time frame: From baseline to Day 99
Maximum (peak) plasma concentration（Cmax）
Time frame: From baseline to Day 99
Chloride（CL）
Time frame: From baseline to Day 99
Terminal elimination half-life（t1/2）
Time frame: From baseline to Day 99
Apparent volume of distribution（Vd）
Time frame: From baseline to Day 99
7 secondary outcomes
Adverse Events(AEs)
Time frame: From baseline to Day 99
Vital signs
Time frame: From baseline to Day 99
Physical examinations
Time frame: From baseline to Day 99
Clinical laboratory tests
Time frame: From baseline to Day 99
12-lead ECGs
Time frame: From baseline to Day 99
Positive rate of serum anti-drug antibody (ADA)
Time frame: From baseline to Day 99
Positive rate of neutralizing antibody (NAb)
Time frame: From baseline to Day 99
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 5 Nov 2021.
- Derived from this study: PubMed 34913787Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin(R) in healthy Chinese male subjects. Expert Opin Biol Ther. 2022 Feb;22(2):263-269. doi: 10.1080/14712598.2022.2019703. Epub 2021 Dec 27.
- Individual participant dataSharing planned: No
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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 LY01008 and Avastin in people with Metastatic Colorectal Cancer and Non Small Cell Lung Cancer Metastatic, run by Shandong Boan Biotechnology 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 6 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 5 Nov 2021. 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?
Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t） (time frame: From baseline to Day 99). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110118, which also lists 1 linked publication.
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 5 Nov 2021.