HealthyPhase 1NCT05449535
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
A Phase 1 study testing JYB1904 and Omalizumab in people with Healthy, run by Jemincare at 1 site in China.
Trial summary
This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JYB1904 and Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2022to 10 Jan 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;
- Healthy Chinese subjects aged 18-50 years, male or female;
- Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others.
Who cannot join
- Surgery history within 6 months prior to screening or any surgery schedule during the study;
- Last visit in previous drug clinical trial within 3 months prior to screening;
- Acute diseases occur or receive any medication during the screening period;
- Other conditions unsuitable for the study confirmed by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects
This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.
Read the detailed description
This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.
The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).
Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.
- Conditions
- Healthy
- Being tested
- JYB1904, Omalizumab, JYB1904 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYB1904Drug
Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.
OmalizumabDrug
Also called Xolair
Dosage form: injection, powder, lyophilized, for solution； Usage and dosage matching:dose 1; single-dose; subcutaneous injection in the deltoid region of the upper arm.
JYB1904 PlaceboDrug
Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| JYB1904/JYB1904 Placebo | Experimental | single-dose; subcutaneous injection in the deltoid region of the upper arm. Receives: Drug: JYB1904; Drug: JYB1904 Placebo |
| Omalizumab | Active comparator | single-dose; subcutaneous injection in the deltoid region of the upper arm. Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and features of AEs assessed by CTCAE v5.0
Measured: Baseline through 168 days post-dose
Secondary outcomes (3)
Serum concentrations of JYB1904 and Omalizumab
Serum JYB1904 and Omalizumab assessed by pre-specified methods, and related pharmacokinetic parameters analysis
Measured: Baseline through 168 days post-dose
Serum concentrations of total/free IgE
Serum total/free IgE assessed by a pre-specified method, and related pharmacodynamic parameters analysis
Measured: Baseline through 168 days post-dose
Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Serum ADA and Nab assessed by pre-specified methods, and related immunogenic features analysis
Measured: Baseline through 168 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start7 May 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
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 JemincareThe 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
- Model description
- JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guiling Chen, MD, Principal investigator, Shulan (Hangzhou) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449535
- Sponsor's protocol ID
- JY20210115-Ia
- Other IDs
- CTR20220973
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05449535
- Acronym / sponsor ID
- JY20210115-Ia
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 7 May 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 8 Jul 2022 (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 phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.
Detailed description
This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.
The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).
Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
| Arm | Type | Receives |
|---|---|---|
| JYB1904/JYB1904 Placebo | Experimental | Drug: JYB1904, Drug: JYB1904 Placebosingle-dose; subcutaneous injection in the deltoid region of the upper arm. |
| Omalizumab | Active comparator | Drug: Omalizumabsingle-dose; subcutaneous injection in the deltoid region of the upper arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;
- Healthy Chinese subjects aged 18-50 years, male or female;
- Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others.
Key exclusion criteria (4 listed)
- Surgery history within 6 months prior to screening or any surgery schedule during the study;
- Last visit in previous drug clinical trial within 3 months prior to screening;
- Acute diseases occur or receive any medication during the screening period;
- Other conditions unsuitable for the study confirmed by the investigator.
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 |
|---|---|---|
| JYB1904Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm. | Drug | JYB1904/JYB1904 Placebo |
| OmalizumabAlso: XolairDosage form: injection, powder, lyophilized, for solution； Usage and dosage matching:dose 1; single-dose; subcutaneous injection in the deltoid region of the upper arm. | Drug | Omalizumab |
| JYB1904 PlaceboDosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm. | Drug | JYB1904/JYB1904 Placebo |
Primary outcome
Adverse events (AEs)
Time frame: Baseline through 168 days post-dose
Incidence and features of AEs assessed by CTCAE v5.0
3 secondary outcomes
Serum concentrations of JYB1904 and Omalizumab
Time frame: Baseline through 168 days post-dose
Serum concentrations of total/free IgE
Time frame: Baseline through 168 days post-dose
Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Baseline through 168 days post-dose
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 27 Jun 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.
Guiling Chen, MD principal investigator
Shulan (Hangzhou) Hospital
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 JYB1904 and Omalizumab in people with Healthy, run by Jemincare 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 3 inclusion and 4 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 27 Jun 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 (AEs) (time frame: Baseline through 168 days post-dose). 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 27 Jun 2023.