Staphylococcus Aureus Bloodstream InfectionPhase 1NCT06014736
A Phase I Study of XJ101 in Chinese Healthy Subjects
A Phase 1 study testing XJ101 for Injection in people with Staphylococcus Aureus Bloodstream Infection, 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
- Staphylococcus Aureus Bloodstream Infection
- What is being tested?
- XJ101 for 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
- 15 Aug 2023to 1 Sep 2024
- 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.
- Acute infection within 4 weeks prior to study entry.
- Suffer from diseases caused by Staphylococcus aureus within one year, such as bacteremia, sepsis and pyemia.
- Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during the study period.
- 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.
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- 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 and 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 XJ101 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.
- Being tested
- XJ101 for Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XJ101 for InjectionDrug
XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein.
PlaceboDrug
Placebo contains only excipients.
| Study group | Role | What they receive |
|---|---|---|
| XJ101 for Injection | Experimental | XJ101 via intravenous(IV). Receives: Drug: XJ101 for Injection |
| Placebo | Placebo comparator | Placebo via intravenous(IV). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities.
Measured: From the time of informed consent through 92 days post dose.
Secondary outcomes (10)
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
Measured: From Day 1 through 92 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 92 days post dose.
Maximum Observed Serum Concentration (Cmax)
Measured: From Day 1 through 92 days post dose.
Terminal Phase Elimination Half-life (t1/2)
Measured: From Day 1 through 92 days post dose.
Elimination Rate Constant (Kel)
Measured: From Day 1 through 92 days post dose.
Mean Residence Time (MRT)
Measured: From Day 1 through 92 days post dose.
Apparent Serum Clearance (CL)
Measured: From Day 1 through 92 days post dose.
Apparent Volume of Distribution (Vd)
Measured: From Day 1 through 92 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 92 days post dose.
Anti Drug Antibody (ADA) Assessments - Serum
ADA responses to XJ101
Measured: From Day 1 through 92 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 posted28 Aug 2023
- Study start15 Aug 2023
- Primary completion26 Mar 2024
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus Bloodstream InfectionStudies 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
- NCT06014736
- Sponsor's protocol ID
- XJ101-I
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2023
- Last updated
- 14 Jun 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 14 Jun 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 XJ101 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06014736
- Acronym / sponsor ID
- XJ101-I
- 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
- 15 Aug 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 28 Aug 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 |
|---|---|---|
| XJ101 for Injection | Experimental | Drug: XJ101 for InjectionXJ101 via intravenous(IV). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo via intravenous(IV). |
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 (18 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.
- Acute infection within 4 weeks prior to study entry.
- Suffer from diseases caused by Staphylococcus aureus within one year, such as bacteremia, sepsis and pyemia.
- Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during 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 |
|---|---|---|
| XJ101 for InjectionXJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein. | Drug | XJ101 for Injection |
| PlaceboPlacebo contains only excipients. | Drug | Placebo |
Primary outcome
Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities.
Time frame: From the time of informed consent through 92 days post dose.
10 secondary outcomes
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
Time frame: From Day 1 through 92 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 92 days post dose.
Maximum Observed Serum Concentration (Cmax)
Time frame: From Day 1 through 92 days post dose.
Terminal Phase Elimination Half-life (t1/2)
Time frame: From Day 1 through 92 days post dose.
Elimination Rate Constant (Kel)
Time frame: From Day 1 through 92 days post dose.
Mean Residence Time (MRT)
Time frame: From Day 1 through 92 days post dose.
Apparent Serum Clearance (CL)
Time frame: From Day 1 through 92 days post dose.
Apparent Volume of Distribution (Vd)
Time frame: From Day 1 through 92 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 92 days post dose.
Anti Drug Antibody (ADA) Assessments - Serum
Time frame: From Day 1 through 92 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 14 Jun 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 XJ101 for Injection in people with Staphylococcus Aureus Bloodstream Infection, 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 18 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 14 Jun 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?
Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities. (time frame: From the time of informed consent through 92 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 14 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.