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

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
HRS-7085 tablets
Placebo tablet
Sponsored by
Atridia Pty Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Linear Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HRS-7085 tablets Cohort 1

HRS-7085 tablets Cohort 6

Arm Description

Part 1- HRS-7085 tablets

Part 1- HRS-7085 tablets

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events

Secondary Outcome Measures

Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after HRS-7085 administration
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after HRS-7085 administration
Pharmacokinetics-Tmax
Time to Cmax of HRS-7085
Pharmacokinetics-Cmax
Maximum observed concentration of HRS-7085
Pharmacokinetics-CL/F
Apparent clearance of HRS-7085
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of HRS-7085
Pharmacokinetics-t1/2
Terminal elimination half-life of HRS-7085

Full Information

First Posted
November 27, 2022
Last Updated
April 19, 2023
Sponsor
Atridia Pty Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05638347
Brief Title
A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atridia Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRS-7085 tablets Cohort 1
Arm Type
Experimental
Arm Description
Part 1- HRS-7085 tablets
Arm Title
HRS-7085 tablets Cohort 6
Arm Type
Experimental
Arm Description
Part 1- HRS-7085 tablets
Intervention Type
Drug
Intervention Name(s)
HRS-7085 tablets
Intervention Description
Single oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
Single oral administration
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Time Frame
Start of Treatment to end of study approximately 1 week
Secondary Outcome Measure Information:
Title
Pharmacokinetics-AUC0-last
Description
Area under the concentration-time curve from time 0 to last time point after HRS-7085 administration
Time Frame
Start of Treatment to end of study (approximately 1 week)
Title
Pharmacokinetics-AUC0-inf
Description
Area under the concentration-time curve from time 0 to infinity after HRS-7085 administration
Time Frame
Start of Treatment to end of study (approximately 1 week)
Title
Pharmacokinetics-Tmax
Description
Time to Cmax of HRS-7085
Time Frame
Start of Treatment to end of study (approximately 1 week)
Title
Pharmacokinetics-Cmax
Description
Maximum observed concentration of HRS-7085
Time Frame
Time Frame: Start of Treatment to end of study (approximately 1 week)
Title
Pharmacokinetics-CL/F
Description
Apparent clearance of HRS-7085
Time Frame
Time Frame: Start of Treatment to end of study (approximately 1 week)
Title
Pharmacokinetics-Vz/F
Description
Apparent volume of distribution during terminal phase of HRS-7085
Time Frame
Time Frame: Start of Treatment to end of study (approximately 1 week)
Title
Pharmacokinetics-t1/2
Description
Terminal elimination half-life of HRS-7085
Time Frame
Time Frame: Start of Treatment to end of study (approximately 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

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

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