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

NCT05638347 | Completed Phase 1 DMC

• 1 other identifier: HRS-7085-102-AUS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Start of Treatment to end of study approximately 1 week

Secondary Outcomes (7)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (approximately 1 week)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 1 week)

• Pharmacokinetics-Tmax

  Start of Treatment to end of study (approximately 1 week)

• Pharmacokinetics-Cmax

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

• Pharmacokinetics-CL/F

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

Study Arms (2)

HRS-7085 tablets Cohort 1

EXPERIMENTAL

Part 1- HRS-7085 tablets

Drug: HRS-7085 tablets; Drug: Placebo tablet

HRS-7085 tablets Cohort 6

EXPERIMENTAL

Part 1- HRS-7085 tablets

Drug: HRS-7085 tablets; Drug: Placebo tablet

Interventions

HRS-7085 tablets DRUG

Single oral administration

HRS-7085 tablets Cohort 1; HRS-7085 tablets Cohort 6

Placebo tablet DRUG

Single oral administration

HRS-7085 tablets Cohort 1; HRS-7085 tablets Cohort 6

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 6, 2022
• Study Start: December 5, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

AU (1)