UnknownPhase 1

A Phase I Study of XJ101 in Chinese Healthy Subjects

China38 participantsStarted 2023-08-15

Plain-language 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. Subjects in each cohort will randomly be given experimental drug or a placebo.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: From the time of informed consent through 92 days post dose.

Trial details

NCT IDNCT06014736

SponsorStarmab biologics（Shanghai）Co,.ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-26

View on ClinicalTrials.gov More Staphylococcus Aureus Bloodstream Infection trials