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Completed

NCT Number: NCT06969664

A Trial of SHR7280 in Healthy Subjects

The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510300, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily sign the informed consent form prior to any activities in the trail, demonstrate comprehension of the trial procedures and methodology, and agree to strictly adhere to the protocol throughout the study period.
  • Be aged between 18 and 45 years inclusive (determined at the time of signing the informed consent form).
  • Have a body weight of ≥50 kg for males and ≥45 kg for females, with a Body Mass Index (BMI) between 18 and 26 kg/m² inclusive.
  • Have no plans for pregnancy or sperm/egg donation from the time of signing the inform consent form until 1 week after the last administration of the investigational product, and agree to use highly effective contraceptive measures.

Exclusion criteria

  • Individuals with a history of chronic or serious diseases, or current conditions affecting the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, nervous, or psychiatric systems, and deemed ineligible to participate in this trial by the investigator.
  • Females who are pregnant, breastfeeding, or with a positive serum pregnancy test during the screening or baseline period.
  • History of smoking (average daily cigarette consumption >5 cigarettes) within 3 months prior to randomization, or any use of tobacco products during the study period.
  • History of drug abuse, positive urine drug abuse screen at the screening period.
  • Receipt of live (attenuated) vaccines within 1 month prior to screening or planned administration during the trial (excluding influenza vaccines).
  • Undergoing any surgical procedure within 3 months prior to randomization, incomplete recovery from surgery, or anticipated need for surgery or hospitalization during the trial period.
  • Inability to comply with standardized dietary requirements, intolerance to high-fat meals, or presence of dysphagia.
  • Any condition judged by the investigator to potentially affect drug absorption, distribution, metabolism, or excretion, reduce compliance, or pose other risks that make participation in the study inappropriate.

Treatment and study plan

SHR7280 Tablet

Drug

Oral SHR7280 tablet.

SHR7280 Placebo Tablet

Drug

Oral SHR7280 placebo tablet.

Primary outcomes

  1. Peak concentration (Cmax)

    Time frame: Day 1 to Day 8.

  2. Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t)

    Time frame: Day 1 to Day 8.

  3. Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)

    Time frame: Day 1 to Day 8.

Secondary outcomes

  1. Time to peak concentration (Tmax)

    Time frame: Day 1 to Day 8.

  2. Elimination half-life (t1/2)

    Time frame: Day 1 to Day 8.

  3. Adverse events (AEs)

    Time frame: Day 1 to Day 15.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate Effect of High-Fat Diet on Pharmacokinetics of a Single Oral Dose of SHR7280 Tablets and to Assess the Effect of SHR7280 on QT Interval in Healthy Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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