A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants

A Randomized, Double-blind, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a Single Oral Dose of HRS-4139 in Healthy Participants

This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: HRS-4139 Tablet; Drug: HRS-4139 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Meng Fu; Phone Number: +86-0518-82342973; Email: meng.fu@hengrui.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
      • Contact: Gan Zhou; Phone Number: +86-0731-89753401; Email: Zhougan77@163.com
      • Principal Investigator: Gan Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-4139 tablet group	Drug: HRS-4139 Tablet; HRS-4139 tablet.
Placebo Comparator: HRS-4139 placebo group	Drug: HRS-4139 Placebo; HRS-4139 placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	Evaluation was performed up to Day 36 or Day 72.
Serious Adverse events (SAEs)	Evaluation was performed up to Day 36 or Day 72.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of HRS-4139 in healthy participants		Evaluation was performed up to Day 36 or Day 72.
Peak concentration (Cmax)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Time to peak concentration (Tmax)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Elimination half-life (t1/2)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Apparent clearance (CL/F)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Apparent volume of distribution (Vd/F)	PK parameter.	Evaluation was performed up to Day 36 or Day 72.
Incidence and time of onset of Anti drug antibody (ADA) positivity in healthy participants receiving HRS-4139		Evaluation was performed up to Day 36 or Day 72.

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS-4139-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No