HealthyPhase 1NCT06021574
A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody
A Phase 1 study testing VDJ001 in people with Healthy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects. The main questions it aims to answer are: Safety and tolerability of investigational drug. pharmacokinetics and immunogenicity of investigational drug. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VDJ001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2019to 6 Jan 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form and comply with the protocol to complete the study.
- Age ≥18 years old and ≤45 years old (at the date of signing the informed consent); females weigh between 45.0~75.0kg, males weigh between 50.0~80.0kg, the body mass index ( BMI) within the range of 19.0~26.0kg/m2.
- Function of heart, liver and kidney is normal.
- The blood pregnancy test for female of childbearing age is negative, and the volunteers or their spouses use appropriate and effective contraceptive measures, such as abstinence, intrauterine device and double barrier method from the test period to 6 months after administration of study drugs.
Who cannot join
- Allergic constitution (e.g. allergic to two or more drugs / foods).
- Those who have a clear history of malignant tumors, neurological or mental disorders (including epilepsy or dementia), heart failure, or immunodeficiency or immunosuppressive diseases, or have undergone major surgery within 6 months before randomization.
- Those with severe bleeding factors that affect venous blood collection or those who are unable/unwilling to receive venipuncture.
- Those who have received any vaccines within 6 months before randomization.
- Those who have previously received anti-IL-6 drugs or other monoclonal antibody treatments, or have used any biological agents within 12 months before randomization.
- Those who have administered with other clinical trial drugs within 3 months before randomization.
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- Massive bleeding or whole blood or component blood (> 400ml) donation within 3 months before randomization.
- With active bacterial, viral, fungal, or parasitic infection or any infection that requires systemic anti-infective treatment within 4 weeks before randomization.
- Those who have received any health products or treated by drugs (including prescription drugs such as warfarin, cyclosporine, theophylline, simvastatin, omeprazole, dextromethorphan, over-the-counter drugs, proprietary Chinese medicine, vitamins, dietary supplements, etc.) within 3 months before randomization or those who may receive drugs during the trial.
- Those who have used soft drugs (such as marijuana) within 3 months before randomization or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial; or those with positive drug abuse test results (cocaine, marijuana, morphine, amphetamine, methamphetamine, phencyclidine, benzodiazepines, barbiturates, methadone and tricyclic antidepressants).
- Alcoholics or those who drink regularly within 3 months before randomization, or those with a positive alcohol breath test.
- Those who smoke within 1 month before screening.
- Those with positive results of nicotine test during screening.
- Drinking excessive amounts of tea, coffee and/or caffeinated beverages every day.
- Positive results of γ interferon release test (T-SPOT).
- Positive result for any one of human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus antibody, hepatitis B surface antigen.
- Result of rheumatoid factor, anti-double-stranded DNA antibody, antinuclear antibody, or anti-cyclic citrulline antibody test is abnormal with clinical significance.
- Those who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial period; or those who plan to participate in strenuous exercise (including physical contact exercise or collision exercise) during the trial period.
- Those who schedule to donate blood during the trial period; or plan to receive any biological drugs within 3 months after the administration of study drug or those who plan to receive monoclonal antibody drugs within 9 months after the administration of study drug.
- Those who plan to get pregnant, or to donate sperm or eggs within 6 months after the administration of study drugs.
- Not suitable for enrollment or may not be able to complete the trial due to other reasons determined by investigator.
- For females: be pregnant or lactating; had unprotected sex with their partner within 14 days before the trial; have taken oral contraceptives 30 days before the trial or plan to take them during the trial; or have used or plan to use long-acting estrogen or progesterone injections or implants within 6 months before the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of a Novel Recombinant Humanized Anti Interleukin-6 Receptor Monoclonal Antibody in Healthy Subjects
The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects. The main questions it aims to answer are:
- Safety and tolerability of investigational drug.
- pharmacokinetics and immunogenicity of investigational drug. Participants will receive a single intravenous administration of investigational drug or placebo. Blood samples are collected at specified time points.
- Conditions
- Healthy
- Being tested
- VDJ001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDJ001Drug
a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A single intravenous administration of 1mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo Receives: Drug: VDJ001; Drug: Placebo |
| A single intravenous administration of 2mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo Receives: Drug: VDJ001; Drug: Placebo |
| A single intravenous administration of 4mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo Receives: Drug: VDJ001; Drug: Placebo |
| A single intravenous administration of 8mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo Receives: Drug: VDJ001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Incidence, severity and relation to investigational drugs of adverse events
Measured: up to 57 days
Pharmacokinetics-AUC0-t
area under the concentration-time curve (AUC) from administration to the last measurable concentration
Measured: up to 57 days
Pharmacokinetics-AUC0-inf
AUC extrapolated to infinity
Measured: up to 57 days
Pharmacokinetics-Cmax
maximum serum concentration
Measured: up to 57 days
Pharmacokinetics-Tmax
time to Cmax
Measured: up to 57 days
Pharmacokinetics-t1/2
elimination half-life
Measured: up to 57 days
Pharmacokinetics-Vz
volume of distribution
Measured: up to 57 days
Pharmacokinetics-CLz
clearance rate
Measured: up to 57 days
Pharmacokinetics- λz
elimination rate constant
Measured: up to 57 days
Pharmacokinetics-MRT0-t
mean residence time (MRT) from administration to the last measurable concentration (MRT0-t)
Measured: up to 57 days
Pharmacokinetics-MRT0-inf
MRT extrapolated to infinity
Measured: up to 57 days
Anti-Drug antibody (ADA)
Percentage of subjects tested ADA positive.
Measured: up to 57 days
Neutralizing antibodies (Nab)
Percentage of subjects tested Nab positive.
Measured: up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start28 Jun 2019
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing VDJBio Co., LTD.
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
- Investigators
- Yu Cao, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021574
- Sponsor's protocol ID
- leadingpharm2019013
- Status last verified
- Aug 2023
- First submitted
- 13 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of a Novel Recombinant Humanized Anti Interleukin-6 Receptor Monoclonal Antibody in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06021574
- Acronym / sponsor ID
- leadingpharm2019013
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Beijing VDJBio Co., LTD.
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 1 Sep 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 study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects. The main questions it aims to answer are:
- Safety and tolerability of investigational drug.
- pharmacokinetics and immunogenicity of investigational drug. Participants will receive a single intravenous administration of investigational drug or placebo. Blood samples are collected at specified time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A single intravenous administration of 1mg VDJ001 or placebo | Experimental | Drug: VDJ001, Drug: PlaceboDrug: VDJ001 Drug: Placebo |
| A single intravenous administration of 2mg VDJ001 or placebo | Experimental | Drug: VDJ001, Drug: PlaceboDrug: VDJ001 Drug: Placebo |
| A single intravenous administration of 4mg VDJ001 or placebo | Experimental | Drug: VDJ001, Drug: PlaceboDrug: VDJ001 Drug: Placebo |
| A single intravenous administration of 8mg VDJ001 or placebo | Experimental | Drug: VDJ001, Drug: PlaceboDrug: VDJ001 Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent form and comply with the protocol to complete the study.
- Age ≥18 years old and ≤45 years old (at the date of signing the informed consent); females weigh between 45.0~75.0kg, males weigh between 50.0~80.0kg, the body mass index ( BMI) within the range of 19.0~26.0kg/m2.
- Function of heart, liver and kidney is normal.
- The blood pregnancy test for female of childbearing age is negative, and the volunteers or their spouses use appropriate and effective contraceptive measures, such as abstinence, intrauterine device and double barrier method from the test period to 6 months after administration of study drugs.
Key exclusion criteria (22 listed)
- Allergic constitution (e.g. allergic to two or more drugs / foods).
- Those who have a clear history of malignant tumors, neurological or mental disorders (including epilepsy or dementia), heart failure, or immunodeficiency or immunosuppressive diseases, or have undergone major surgery within 6 months before randomization.
- Those with severe bleeding factors that affect venous blood collection or those who are unable/unwilling to receive venipuncture.
- Those who have received any vaccines within 6 months before randomization.
- Those who have previously received anti-IL-6 drugs or other monoclonal antibody treatments, or have used any biological agents within 12 months before randomization.
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 |
|---|---|---|
| VDJ001a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody | Drug | A single intravenous administration of 1mg VDJ001 or placebo, A single intravenous administration of 2mg VDJ001 or placebo, A single intravenous administration of 4mg VDJ001 or placebo, A single intravenous administration of 8mg VDJ001 or placebo |
| PlaceboPlacebo | Drug | A single intravenous administration of 1mg VDJ001 or placebo, A single intravenous administration of 2mg VDJ001 or placebo, A single intravenous administration of 4mg VDJ001 or placebo, A single intravenous administration of 8mg VDJ001 or placebo |
Primary outcome
adverse events
Time frame: up to 57 days
Incidence, severity and relation to investigational drugs of adverse events
Pharmacokinetics-AUC0-t
Time frame: up to 57 days
area under the concentration-time curve (AUC) from administration to the last measurable concentration
Pharmacokinetics-AUC0-inf
Time frame: up to 57 days
AUC extrapolated to infinity
Pharmacokinetics-Cmax
Time frame: up to 57 days
maximum serum concentration
Pharmacokinetics-Tmax
Time frame: up to 57 days
time to Cmax
Pharmacokinetics-t1/2
Time frame: up to 57 days
elimination half-life
Pharmacokinetics-Vz
Time frame: up to 57 days
volume of distribution
Pharmacokinetics-CLz
Time frame: up to 57 days
clearance rate
Pharmacokinetics- λz
Time frame: up to 57 days
elimination rate constant
Pharmacokinetics-MRT0-t
Time frame: up to 57 days
mean residence time (MRT) from administration to the last measurable concentration (MRT0-t)
Pharmacokinetics-MRT0-inf
Time frame: up to 57 days
MRT extrapolated to infinity
Anti-Drug antibody (ADA)
Time frame: up to 57 days
Percentage of subjects tested ADA positive.
Neutralizing antibodies (Nab)
Time frame: up to 57 days
Percentage of subjects tested Nab positive.
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 1 Sep 2023.
- 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.
Yu Cao principal investigator
The Affiliated Hospital of Qingdao 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 VDJ001 in people with Healthy, run by The Affiliated Hospital of Qingdao University 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 22 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 1 Sep 2023. 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?
adverse events (time frame: up to 57 days). The study lists 13 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 1 Sep 2023.