Pneumococcal DiseasePhase 1NCT06026748
A Phase I Study of XJ103 in Chinese Healthy Subjects
A Phase 1 study testing XJ103 Injection in people with Pneumococcal Disease, run by Starmab biologics（Shanghai）Co,.ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- XJ103 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2023to 6 Mar 2025
- 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
- Age 18 through 45 years at screening.
- Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including critical values).
- The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the informed consent form until the end of the trail.
- Healthy on the basis of physical examination and medical and surgical history and twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities.
- Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
Who cannot join
- Subjects with any abnormalities of respiratory system, circulatory system, digestive system, nervous system, skeletal muscle system, blood and lymphatic system, immune system and endocrine system.
- History of allergy to drugs or biological products or individuals with allergic constitution.
- Acute infection within 4 weeks prior to study entry.
- Suffer from diseases caused by streptococcus pneumoniae within 1 year prior to study entry, such as pneumococcal pneumonia, pneumococcal meningitis, etc.
- Receipt of any standard vaccine against streptococcus pneumoniae before the study period.
- Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during the study period.
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- Receipt of any major surgery within 3 months prior to the start of the trial, or have not recovered from surgery, or plan to have a surgical during the trial.
- Those who cannot tolerate venipuncture, or have a history of injector and blood sickness, or are not suitable for venous blood collection.
- Subjects with a history of drug abuse or drug use, or those with positive urine drug screening.
- Blood donation or massive blood loss (> 200 mL) within three months prior to screening or plan to donate blood, receive blood transfusions, or use blood products during the trial period or within 1 month after the end of the trial.
- Pregnant or lactating women.
- Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening.
- Smoke more than 5 cigarettes per day within three months prior to screening.
- Frequent drinkers in the three months before screening, i.e. those who drink more than or equal to 14 units of alcohol per week on average (1 unit=17.7 ml ethanol, 1 unit=354 ml beer with 5% alcohol, 44.25 ml spirits with 40% alcohol, or 147.5 ml wine with 12% alcohol), or those who do not agree to ban alcohol during the study period.
- Evidence of infection with HBV, hepatitis C, HIV, or syphilis.
- Positive alcohol breath test.
- Subjects with special dietary requirements or cannot accept a unified diet.
- Participation in other clinical trials within three months prior to enrollment or plan to participate in other clinical trials during this period.
- Any other factors evaluated by investigators that patients cannot be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ103 in Chinese Healthy Subjects
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.
- Conditions
- Pneumococcal Disease
- Being tested
- XJ103 Injection, Placebo
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XJ103 InjectionDrug
XJ103 is a humanized monoclonal antibody.
PlaceboDrug
Placebo contains only excipients.
| Study group | Role | What they receive |
|---|---|---|
| XJ103 Injection | Experimental | Participants will receive a single dose of XJ103 intravenously. Receives: Drug: XJ103 Injection |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any adverse events that occurred among all subjects during the clinical trial
Measured: From the time of informed consent through 358 days post dose.
Secondary outcomes (11)
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
Measured: From Day 1 through 358 days post dose.
Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])
Measured: From Day 1 through 358 days post dose.
Maximum Observed Serum Concentration (Cmax)
Measured: From Day 1 through 358 days post dose.
Terminal Phase Elimination Half-life (t1/2)
Measured: From Day 1 through 358 days post dose.
Elimination Rate Constant (Kel)
Measured: From Day 1 through 358 days post dose.
Mean Residence Time (MRT)
Measured: From Day 1 through 358 days post dose.
Apparent Serum Clearance (CL)
Measured: From Day 1 through 358 days post dose.
Apparent Volume of Distribution (Vd)
Measured: From Day 1 through 358 days post dose.
Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)
Measured: From Day 1 through 358 days post dose.
Proportion of Participants Positive for Anti-drug Antibodies (ADA)
Measured: From Day 1 through 358 days post dose.
Titer Range of Anti-drug Antibodies (ADA)
Measured: From Day 1 through 358 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 posted7 Sep 2023
- Study start12 Sep 2023
- Primary completion24 Dec 2024 (estimated)
- Study completion6 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starmab biologics（Shanghai）Co,.ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ding xueying, Study director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026748
- Sponsor's protocol ID
- XJ103-I
- Status last verified
- Mar 2024
- First submitted
- 24 Aug 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ103 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06026748
- Acronym / sponsor ID
- XJ103-I
- Conditions
- Pneumococcal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Starmab biologics（Shanghai）Co,.ltdIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 6 Mar 2025 (estimated)
- First posted
- 7 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.
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XJ103 Injection | Experimental | Drug: XJ103 InjectionParticipants will receive a single dose of XJ103 intravenously. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo intravenously. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 through 45 years at screening.
- Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including critical values).
- The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the informed consent form until the end of the trail.
- Healthy on the basis of physical examination and medical and surgical history and twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities.
- Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
Key exclusion criteria (19 listed)
- Subjects with any abnormalities of respiratory system, circulatory system, digestive system, nervous system, skeletal muscle system, blood and lymphatic system, immune system and endocrine system.
- History of allergy to drugs or biological products or individuals with allergic constitution.
- Acute infection within 4 weeks prior to study entry.
- Suffer from diseases caused by streptococcus pneumoniae within 1 year prior to study entry, such as pneumococcal pneumonia, pneumococcal meningitis, etc.
- Receipt of any standard vaccine against streptococcus pneumoniae before the study period.
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 |
|---|---|---|
| XJ103 InjectionXJ103 is a humanized monoclonal antibody. | Drug | XJ103 Injection |
| PlaceboPlacebo contains only excipients. | Drug | Placebo |
Primary outcome
Incidence of any adverse events that occurred among all subjects during the clinical trial
Time frame: From the time of informed consent through 358 days post dose.
11 secondary outcomes
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
Time frame: From Day 1 through 358 days post dose.
Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])
Time frame: From Day 1 through 358 days post dose.
Maximum Observed Serum Concentration (Cmax)
Time frame: From Day 1 through 358 days post dose.
Terminal Phase Elimination Half-life (t1/2)
Time frame: From Day 1 through 358 days post dose.
Elimination Rate Constant (Kel)
Time frame: From Day 1 through 358 days post dose.
Mean Residence Time (MRT)
Time frame: From Day 1 through 358 days post dose.
Apparent Serum Clearance (CL)
Time frame: From Day 1 through 358 days post dose.
Apparent Volume of Distribution (Vd)
Time frame: From Day 1 through 358 days post dose.
Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)
Time frame: From Day 1 through 358 days post dose.
Proportion of Participants Positive for Anti-drug Antibodies (ADA)
Time frame: From Day 1 through 358 days post dose.
Titer Range of Anti-drug Antibodies (ADA)
Time frame: From Day 1 through 358 days post dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
Ding xueying study director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 XJ103 Injection in people with Pneumococcal Disease, run by Starmab biologics（Shanghai）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 19 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: status not confirmed, as of the sponsor's last update on 27 Mar 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. Some participants in this study may receive a placebo. 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?
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?
Incidence of any adverse events that occurred among all subjects during the clinical trial (time frame: From the time of informed consent through 358 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 Mar 2024.