Healthy Male VolunteersPhase 1NCT03863587
Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects
A Phase 1 study testing HLX12 and Cyramza (Ramucirumab) in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The study consists of 2 parts: Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in… 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
- Healthy Male Volunteers
- What is being tested?
- HLX12 and Cyramza (Ramucirumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2019to 24 Sep 2019
- 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
- Healthy adult male aged 18-50 years (including 18 and 50 years old) with a body mass index of 18-28 kg/m2 (including 18 kg/m2 and 28 kg/m2), weighing ≥50 kg and ≤80 kg;
Who cannot join
- Previous or current atopic allergies, hypersensitivity reactions, or allergic reactions that are clinically significant, including known or suspected clinically relevant drug allergies to a component of the study drug or the control drug; Any disease that may affect the safety of the subject or affect the study operation and assessment, according to the investigator's judgment; Have undergone surgery in the past 8 weeks, or are planned for surgery during the study period; Have been inoculated with live virus vaccine within 4 weeks prior to screening, or intend to be inoculated with live virus vaccine during the study period until the end of the last follow-up; Any prior history of exposure to anti-VEGF or anti-VEGF receptor monoclonal antibodies/proteins; Exposure to any monoclonal antibody within 12 months prior to study drug administration; Have used any clinical study drug within 3 months prior to screening, or are still in the follow-up period of a clinical study; Have taken non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to the study drug administration, including any dose of aspirin. NSAIDs (except acetaminophen) shall not be used during the study; QTc interval > 450 ms; ECG is abnormal and the abnormality is clinicaly significant as judged by the investigator; Have taken any alcoholic products within 48 hours prior to the study drug administration; Subjects who have a family history of hypertension, or are found with abnormal blood pressure at screening or on admission to the study site (Day-1): systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, which is judged by the investigator as clinically significant ; Have a genetic predisposition to bleeding or thrombosis, or a history of bleeding due to non-trauma (ie, bleeding requiring medical intervention), a thromboembolic event, or any condition that may increase the risk of bleeding, including coagulopathy, thrombocytopenia (platelet count <100109/L) or international normalized ratio (INR) higher than 1.5;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-controlled, Intravenous Single-dose, Phase I Clinical Study Comparing the Pharmacokinetic Profile, Safety, Tolerability and Immunogenicity of HLX12 and Cyramza (Ramucirumab) in Healthy Male Adult Subjects
The study consists of 2 parts:
Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects. The number of subjects is set to 24, who will be randomized into two groups, and each group has the same number of subjects (n=12). Group 1 will receive intravenous infusion of the test preparation T HLX12, while Group 2 will receive Cyramza, once in both groups.
Part II study: to compare the PK similarity between HLX12 and Cyramza This study is a randomized, double-blind, parallel-controlled, intravenous single-dose Phase I clinical study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects.The number of subjects is set to 128, and the treatment is the same with Part I study.
- Conditions
- Healthy Male Volunteers
- Being tested
- HLX12, Cyramza (Ramucirumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX12Biological
healthy volunters receive HLX12 (8mg/kg) once
Cyramza (Ramucirumab)Biological
healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once
| Study group | Role | What they receive |
|---|---|---|
| HLX12 group | Experimental | HLX12 are given intravenous infusion 8 mg/kg, prepared with normal saline to an administration volume of 250 mL, and the administration time is 90 min (± 10 min). Receives: Biological: HLX12 |
| Cyramza (Ramucirumab) group | Active comparator | Ramucirumab are given intravenous infusion of Cyramza 8 mg/kg, prepared with normal saline to an administration volume of 250 mL, and the administration time is 90 min (± 10 min). Receives: Biological: Cyramza (Ramucirumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0~inf
Area under curve from zero to infinity
Measured: from predose to 1680 hours (Day 71),18 timepoints
Secondary outcomes (5)
safety and tolerability of two groups
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: from day1 to day 71
safety and tolerability of two groups
Number of AE as assessed by CTCAE v5.0
Measured: from day1 to day 71
safety and tolerability of two groups
AE listing as assessed by CTCAE v5.0
Measured: from day1 to day 71
AUC0~t
area under the concentration-time curve
Measured: from predose to 1680 hours (Day 71),18 timepoints
Cmax
maximum concentration
Measured: from predose to 1680 hours (Day 71),18 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start6 Jun 2019
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Why it stopped: The study was terminated prematurely due to the difficulty in recruiting participants caused by the COVID-19 pandemic.
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 Healthy Male VolunteersStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Principal investigator, First Hospital of Jinlin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863587
- Sponsor's protocol ID
- HLX12-001
- Status last verified
- Apr 2022
- First submitted
- 25 Feb 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.
PubMed 35132630
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-controlled, Intravenous Single-dose, Phase I Clinical Study Comparing the Pharmacokinetic Profile, Safety, Tolerability and Immunogenicity of HLX12 and Cyramza (Ramucirumab) in Healthy Male Adult Subjects
- ClinicalTrials.gov ID
- NCT03863587
- Acronym / sponsor ID
- HLX12-001
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to the difficulty in recruiting participants caused by the COVID-19 pandemic.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 5 Mar 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.
The study consists of 2 parts:
Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects. The number of subjects is set to 24, who will be randomized into two groups, and each group has the same number of subjects (n=12). Group 1 will receive intravenous infusion of the test preparation T HLX12, while Group 2 will receive Cyramza, once in both groups.
Part II study: to compare the PK similarity between HLX12 and Cyramza This study is a randomized, double-blind, parallel-controlled, intravenous single-dose Phase I clinical study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects.The number of subjects is set to 128, and the treatment is the same with Part I study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX12 group | Experimental | Biological: HLX12HLX12 are given intravenous infusion 8 mg/kg, prepared with normal saline to an administration volume of 250 mL, and the administration time is 90 min (± 10 min). |
| Cyramza (Ramucirumab) group | Active comparator | Biological: Cyramza (Ramucirumab)Ramucirumab are given intravenous infusion of Cyramza 8 mg/kg, prepared with normal saline to an administration volume of 250 mL, and the administration time is 90 min (± 10 min). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult male aged 18-50 years (including 18 and 50 years old) with a body mass index of 18-28 kg/m2 (including 18 kg/m2 and 28 kg/m2), weighing ≥50 kg and ≤80 kg;
Key exclusion criteria (1 listed)
- Previous or current atopic allergies, hypersensitivity reactions, or allergic reactions that are clinically significant, including known or suspected clinically relevant drug allergies to a component of the study drug or the control drug; Any disease that may affect the safety of the subject or affect the study operation and assessment, according to the investigator's judgment; Have undergone surgery in the past 8 weeks, or are planned for surgery during the study period; Have been inoculated with live virus vaccine within 4 weeks prior to screening, or intend to be inoculated with live virus vaccine during the study period until the end of the last follow-up; Any prior history of exposure to anti-VEGF or anti-VEGF receptor monoclonal antibodies/proteins; Exposure to any monoclonal antibody within 12 months prior to study drug administration; Have used any clinical study drug within 3 months prior to screening, or are still in the follow-up period of a clinical study; Have taken non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to the study drug administration, including any dose of aspirin. NSAIDs (except acetaminophen) shall not be used during the study; QTc interval > 450 ms; ECG is abnormal and the abnormality is clinicaly significant as judged by the investigator; Have taken any alcoholic products within 48 hours prior to the study drug administration; Subjects who have a family history of hypertension, or are found with abnormal blood pressure at screening or on admission to the study site (Day-1): systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, which is judged by the investigator as clinically significant ; Have a genetic predisposition to bleeding or thrombosis, or a history of bleeding due to non-trauma (ie, bleeding requiring medical intervention), a thromboembolic event, or any condition that may increase the risk of bleeding, including coagulopathy, thrombocytopenia (platelet count <100109/L) or international normalized ratio (INR) higher than 1.5;
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 |
|---|---|---|
| HLX12healthy volunters receive HLX12 (8mg/kg) once | Biological | HLX12 group |
| Cyramza (Ramucirumab)healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once | Biological | Cyramza (Ramucirumab) group |
Primary outcome
AUC0~inf
Time frame: from predose to 1680 hours (Day 71),18 timepoints
Area under curve from zero to infinity
5 secondary outcomes
safety and tolerability of two groups
Time frame: from day1 to day 71
safety and tolerability of two groups
Time frame: from day1 to day 71
safety and tolerability of two groups
Time frame: from day1 to day 71
AUC0~t
Time frame: from predose to 1680 hours (Day 71),18 timepoints
Cmax
Time frame: from predose to 1680 hours (Day 71),18 timepoints
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to the difficulty in recruiting participants caused by the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 35132630American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.
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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 principal investigator
First Hospital of Jinlin 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 HLX12 and Cyramza (Ramucirumab) in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 May 2022. 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 was stopped early (reason given: The study was terminated prematurely due to the difficulty in recruiting participants caused by the COVID-19 pandemic.). Results are not available in the source record.
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~inf (time frame: from predose to 1680 hours (Day 71),18 timepoints). 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 NCT03863587, 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 10 May 2022.