A single-dose SHR-7012 safety study in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, Phase 1 trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single SHR-7012 injection compared with placebo in healthy adults aged 18 to 55. Participants will receive either SHR-7012 or placebo in a controlled setting, with careful monitoring for adverse effects and laboratory changes. The study aims to understand how the drug is processed in the body and its initial biological effects, to inform future research in patients with cutaneous lupus erythematosus. Enrollment is limited to adults meeting specific health and contraception criteria, and the trial is conducted at Zhejiang Provincial People’s Hospital under Guangdong Hengrui Pharmaceutical Co., Ltd as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.
2. 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)
3. 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
4. Female participants: not pregnant or lactatin
5. 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:

1. 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
2. Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection
3. Patients with chronic or recurrent infection requiring treatment within 12 months before screening
4. A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive
5. There was a previous history of risk factors for torsades de pointes
6. Patients who had undergone major surgery within 6 months before screening
7. Persons who had been vaccinated within 1 month before screening or planned to be vaccinated during the trial
8. 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
9. Participants who had participated in a clinical trial and received a trial drug within 3 months before screening or who planned to participate in another clinical trial during the trial
10. Patients were screened if they had donated or lost at least 400 mL of blood (except physiological blood loss in women) within 3 months before the trial, received a transfusion or used blood products, or were planning to donate blood during or within 1 month after the trial
11. People who have special dietary requirements and cannot follow a uniform diet
12. Those with a history of drug abuse, drug use, or a positive screening test for drug abuse
13. Those who have difficulty in venous blood collection/cannot tolerate venipuncture, or have a history of fainting or fainting
14. If the site of administration was abnormal, the investigator judged that subcutaneous administration was not suitable
15. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment

Where it's running

• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yuqing Huang
• Email: yuqing.huang@hengrui.com
• Phone: +0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.