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

NCT05274516 | Completed Phase 1

• 1 other identifier: HRS-2261-101
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Area under the curve (AUC)

  up to 7 days after the last dose

• Maximum plasma concentration (Cmax)

  up to 7 days after the last dose

• Area under the curve (AUC) under fed conditions

  up to 7 days after the last dose

• Maximum plasma concentration (Cmax) under fed conditions

  up to 7 days after the last dose

Study Arms (2)

Single Ascending Doses, 6 dose levels

EXPERIMENTAL

HRS-2261 oral tablet Matching placebo to HRS-2261

Drug: HRS-2261 tablet、placebo

Multiple Ascending Doses, 3 dose levels

EXPERIMENTAL

HRS-2261 oral tablet Matching placebo to HRS-2261

Drug: HRS-2261 tablet、placebo

Interventions

HRS-2261 tablet、placebo DRUG

HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.

Single Ascending Doses, 6 dose levels

Eligibility Criteria

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

You may qualify if:

• Able and willing to provide a written informed consent.
• Age 18 to 55 years (inclusive).
• Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
• 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.

You may not qualify if:

• 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.
• 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.
• Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
• Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
• 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.
• 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.
• 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.
• Subjects with a history of drug abuse, drug dependence or positive drug screening.
• Determined by the investigator to be unfit to participate in this clinical trial.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The second hospital of Anhui Medical University

Hefei, Anhui, 510120, China

Location

Related Publications (1)

• Fan Y, Zhang X, Zhang Q, Zheng L, Zhou R, Sun C, Wang X, Song K, He Z, Wang H, Zhang Q, Hu W. Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2024 Mar;63(3):293-302. doi: 10.1007/s40262-023-01330-7. Epub 2024 Jan 10.

  PMID: 38198010 DERIVED

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-2261 compared with placebo

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 10, 2022
• Study Start: March 28, 2022
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: April 5, 2023

Record last verified: 2022-10

Locations

CN (1)