A Trial of HBM9378 in Healthy Chinese Subjects (NCT05790694) | Clinical Trial Compass
CompletedPhase 1
A Trial of HBM9378 in Healthy Chinese Subjects
China50 participantsStarted 2022-09-23
Plain-language summary
The objective is to evaluate the safety, tolerability and pharmacokinetic profile of a single subcutaneous injection of HBM9378 (SKB378) at different doses in healthy Chinese subjects.
Who can participate
Age range
18 Years – 50 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
. Written informed consent must be obtained.
. Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities.
. Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive).
. Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ;
. Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study.
. Can communicate successfully with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
. History of relevant allergy/hypersensitivity.
. History of any of the following diseases:
. Any clinically significant comorbidity, as judged by the investigator.
. Clinical signs of active infection found at screening.
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
1
Adverse events
Timeframe: Strat of Treatment to end of study (approsimately 160days)
2
Pharmacokinetics-AUC0-last
Timeframe: Strat of Treatment to end of study (approsimately 160days)
3
Pharmacokinetics-Tmax
Timeframe: Strat of Treatment to end of study (approsimately 160days)
4
Pharmacokinetics-Cmax
Timeframe: Strat of Treatment to end of study (approsimately 160days)
5
Pharmacokinetics-CL/F
Timeframe: Strat of Treatment to end of study (approsimately 160days)
6
Pharmacokinetics-Vd/F
Timeframe: Strat of Treatment to end of study (approsimately 160days)
7
Pharmacokinetics-T1/2
Timeframe: Strat of Treatment to end of study (approsimately 160days)