HRS-4139 safety and pharmacology 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 is a Phase 1 interventional trial evaluating a single oral dose of HRS-4139 in healthy participants. The study will assess safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics to understand how the drug behaves in the body and its initial biological effects. Participants will be randomly assigned to receive either HRS-4139 or placebo under closely monitored conditions. The trial will recruit adults 18 to 55 years old with specific BMI and weight ranges and will exclude individuals with several medical conditions or risk factors that could confound results. The lead sponsor is Fujian Shengdi Pharmaceutical Co., Ltd., with the Xiangya Hospital site handling study conduct.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written informed consent.
2. Participants aged 18 to 55 years (inclusive) at screening.
3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m² (inclusive).
4. Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol.

Exclusion Criteria:

1. Participants with any disease of the circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with the trial results.
2. Participants with a history of malignancy.
3. Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short QT syndrome or long QT syndrome, or with a family history in first-degree relatives of unexplained sudden death, drowning, or sudden infant death syndrome (SIDS) occurring at ≤ 40 years of age.
4. Participants who have had an opportunistic infection within 6 months prior to screening; or who have a known history of recurrent or chronic infections, or who have had chronic or recurrent sinusitis, tonsillitis, urinary tract infections, prostatitis, enteritis, etc.
5. Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening.
6. Participants who have participated in any clinical trial of a drug or medical device within 3 months prior to screening, where participation is defined as having signed the informed consent and having received the investigational drug or medical device; or Participants who are still within the follow-up period of any clinical study or within 5 elimination half-lives of the study drug at the time of screening, whichever is longer.
7. Participants who have used any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, etc.) within 2 weeks or within 5 elimination half-lives (whichever is longer) prior to the administration of the study drug; or Participants who plan to use any other medication during the study period.
8. Participants who have received a live (attenuated) vaccine within 1 month prior to screening or plan to receive such a vaccine during the trial period, with the exception of influenza vaccination.
9. Participants who have experienced severe trauma or undergone major surgery within 6 months prior to screening, or who plan to undergo surgery during the trial period.
10. Participants who have donated blood or experienced significant blood loss (≥ 400 mL) within 1 month prior to screening, or who have received a blood transfusion within 2 months prior to screening.

Where it's running

• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Meng Fu
• Email: meng.fu@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Total Coumarin botanical cream for psoriasis vulgaris

  This trial will try a botanical Total Coumarin cream applied twice daily for 8 weeks to see if it helps adults with mild to moderate psoriasis.

  Recruiting Phase 3 Psoriasis Research Institute of Guangzhou · New York, New York · NCT07426120

• Topical diacerein in plaque psoriasis (adult) explores if a cream helps skin improve

  This trial tests whether applying a topical diacerein cream twice daily for 8 weeks helps adults with mild-to-moderate psoriasis vulgaris improve symptoms more than a placebo.

  Recruiting Phase 4 Cairo University · Cairo · NCT07352306

• Vaspin gene changes and blood vaspin levels in people with psoriasis

  This test will see if specific vaspin gene variants are linked to blood vaspin levels in people with psoriasis.

  Recruiting Aswan University · Aswān · NCT07320872

• Optimizing biologic dosing for psoriasis treatment

  This study is testing if a new way of adjusting psoriasis medication based on blood tests can work just as well as the usual method over 18 months.

  Recruiting at 10 sites Phase 4 University Hospital, Ghent · Bruges and 14 other locations · NCT06398106

• Treatment of psoriasis with deucravacitinib

  This study is testing how well a new medication called deucravacitinib can change immune cell behavior in people with moderate to severe psoriasis.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT05858645

• Shuiniujiao Dihuang Decoction With Variation for Psoriasis

  A 12-week study tests whether the Chinese medicine formula Shuiniujiao Dihuang Decoction with Variation can help people with mild to moderate plaque psoriasis compared with placebo.

  Recruiting Phase 2 Chinese University of Hong Kong · Hong Kong · NCT05815797

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.