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Completed

NCT Number: NCT05638347

A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
  • Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
  • Total body weight 45 kg~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
  • For healthy subjects, no clinically significant abnormalities.
  • Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion criteria

  • Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
  • Severe injuries or major surgeries within 3 months before dosing.
  • Subjects with infectious disease.
  • Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
  • Blood donation or loss of ≥ 200 mL of blood within 1 month prior to dosing, or ≥ 400 mL of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing.
  • Clinically significant abnormalities in 12-Lead ECG
  • More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening, or positive cotinine test at screening or baseline.
  • Positive urine drug at screening or baseline.
  • Subject who cannot perform venous blood sampling.
  • Known history or suspected of being allergic to the study drugs and their excipients.
  • Use of prescription medicine within 2 weeks, or OTC medicine, within 1-week or 5 half-lives prior to dosing.
  • History of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline.
  • Participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing.
  • Special dietary requirements that cannot follow the meal plan in the food effect study.
  • In the investigator's judgment, may increase the risk to the subject.
  • Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.

Treatment and study plan

HRS-7085 tablets

Drug

Single oral administration

Placebo Tablet

Drug

Single oral administration

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: Start of Treatment to end of study approximately 1 week

Secondary outcomes

  1. Pharmacokinetics-AUC0-last

    Time frame: Start of Treatment to end of study (approximately 1 week)

    Area under the concentration-time curve from time 0 to last time point after HRS-7085 administration

  2. Pharmacokinetics-AUC0-inf

    Time frame: Start of Treatment to end of study (approximately 1 week)

    Area under the concentration-time curve from time 0 to infinity after HRS-7085 administration

  3. Pharmacokinetics-Tmax

    Time frame: Start of Treatment to end of study (approximately 1 week)

    Time to Cmax of HRS-7085

  4. Pharmacokinetics-Cmax

    Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)

    Maximum observed concentration of HRS-7085

  5. Pharmacokinetics-CL/F

    Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)

    Apparent clearance of HRS-7085

  6. Pharmacokinetics-Vz/F

    Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)

    Apparent volume of distribution during terminal phase of HRS-7085

  7. Pharmacokinetics-t1/2

    Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)

    Terminal elimination half-life of HRS-7085

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

Use the Protocol Title. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect on the Pharmacokinetics of HRS-7085 in Healthy Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2022
Registry last updated
Apr 21, 2023

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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