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

NCT07802964 | Recruiting Phase 1

• 1 other identifier: HRS-4139-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Plasma concentration of HRS-4139 in healthy participants

  Evaluation was performed up to Day 36 or Day 72.

• Peak concentration (Cmax)

  Evaluation was performed up to Day 36 or Day 72.

• Time to peak concentration (Tmax)

  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)

  Evaluation was performed up to Day 36 or Day 72.

• Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

  Evaluation was performed up to Day 36 or Day 72.

Study Arms (2)

HRS-4139 tablet group

EXPERIMENTAL

Drug: HRS-4139 Tablet

HRS-4139 placebo group

PLACEBO COMPARATOR

Drug: HRS-4139 Placebo

Interventions

HRS-4139 Tablet DRUG

HRS-4139 tablet.

HRS-4139 tablet group

HRS-4139 Placebo DRUG

HRS-4139 placebo.

HRS-4139 placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Participants with a history of malignancy.
• 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.
• 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.
• Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Central Study Contacts

Meng Fu

CONTACT

+86-0518-82342973; meng.fu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

CN (1)