A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration

Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of HRS-2261, the Effects of Food on the Pharmacokinetics of HRS-2261, and the Effects of HRS-2261 on CYP3A4 Metabolic Enzymes in Healthy Subjects After Single and Multiple Oral Administration

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.

Study Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: HRS-2261 tablet、placebo; Drug: HRS-2261 tablet、placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 510120
      • The second hospital of Anhui medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Age 18 to 55 years (inclusive).
3. Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
4. Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.

Exclusion Criteria:

1. Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
2. Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
3. Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
4. Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
5. Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
6. Subjects who had a history of smoking in the previous 3 months (average daily smoking > 5 cigarettes), or who could not stop using any tobacco products during the test period.
7. Subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 mL beer, 150 mL wine or about 50mL low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period.
8. Subjects with a history of drug abuse, drug dependence or positive drug screening.
9. Determined by the investigator to be unfit to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Doses, 6 dose levels; HRS-2261 oral tablet Matching placebo to HRS-2261	Drug: HRS-2261 tablet、placebo; HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.; Drug: HRS-2261 tablet、placebo; HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.
Experimental: Multiple Ascending Doses, 3 dose levels; HRS-2261 oral tablet Matching placebo to HRS-2261	Drug: HRS-2261 tablet、placebo; HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.; Drug: HRS-2261 tablet、placebo; HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of treatment emergent adverse events (TEAEs)	Number and severity of TEAEs collected from dosing until follow up 7 days after last dose	up to 7 days after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC)	To assess AUC of single and multiple ascending oral doses of HRS-2261	up to 7 days after the last dose
Maximum plasma concentration (Cmax)	To assess Cmax of single and multiple ascending oral doses of HRS-2261	up to 7 days after the last dose
Area under the curve (AUC) under fed conditions	To assess AUC of a single oral dose of HRS-2261 under fed conditions	up to 7 days after the last dose
Maximum plasma concentration (Cmax) under fed conditions	To assess Cmax of a single oral dose of HRS-2261 under fed conditions	up to 7 days after the last dose

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HRS-2261-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No