A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of S… (NCT07749651) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
China50 participantsStarted 2026-08
Plain-language summary
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
Who can participate
Age range
18 Years – 55 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
. The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.
. Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value)
. Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods
. Female participants: not pregnant or lactatin
. Before the trial, the participants had understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial in detail, were able to understand the procedures and methods of the study, were willing to strictly abide by the requirements of the entire clinical study, and voluntarily signed informed consent
Exclusion criteria
. Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment
. Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection
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
Safety and tolerability : Incidence and severity of any adverse events
. Patients with chronic or recurrent infection requiring treatment within 12 months before screening
. A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive
. There was a previous history of risk factors for torsades de pointes
. Patients who had undergone major surgery within 6 months before screening
. Persons who had been vaccinated within 1 month before screening or planned to be vaccinated during the trial
. Anyone who had taken any medication or health product (including Chinese herbal medicine) within 7 half-lives or 14 days before dose, whichever was longer, or who had known during the screening period that they might need to receive additional medication during the trial