QR052107B Tablets in Patients With Subacute Cough of Phase Ⅱ Study

NCT06920836 | Completed Phase 2

• 1 other identifier: QR052107B-YJXKS-2-1
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to Evaluate the Efficacy and Safety of QR052107B 100mg， QR052107B 400mg in Patients with Subacute Cough.

Conditions

Cough

Keywords

Subacute Cough; selective P2X3 antagonist

Outcome Measures

Primary Outcomes (1)

• GMR of mean coughs per hour within 24 hours on D10 versus baseline

  The geometric mean ratio (GMR) of mean coughs per hour within 24 hours on day10 versus baseline.

  Baseline and day 10

Secondary Outcomes (8)

• GMR of mean coughs per hour within 24 h on D10 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline

  Baseline and day 10

• GMR of mean coughs per hour within 24 h on D4 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline

  Baseline and day 4

• GMR of mean coughs per hour within 24 hours on D4 versus baseline

  Baseline and day 4

• GMR of mean awake coughs per hour on D10 versus baseline

  Baseline and day 10

• GMR of mean awake coughs per hour on D4 versus baseline

  Baseline and day 4

Study Arms (3)

QR052107B 100 mg QD

ACTIVE COMPARATOR

Participants will be treated with one tablet of QR052107B 100mg, three tablets of placebo once daily for up to 9 days.

Drug: QR052107B 100 mg

QR052107B 400 mg QD

ACTIVE COMPARATOR

Participants will be treated with four tablets of QR052107B 100mg once daily for up to 9 days.

Drug: QR052107B 400 mg

placebo QD

PLACEBO COMPARATOR

Participants will be treated with four tablets of placebo once daily for up to 9 days.

Drug: Placebo

Interventions

QR052107B 100 mg DRUG

QR052107B 100 mg QD

QR052107B 100 mg QD

QR052107B 400 mg DRUG

QR052107B 400 mg QD

QR052107B 400 mg QD

Placebo DRUG

placebo QD

placebo QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 (both inclusive), male or female.
• Subjects with 18 kg/m2 ≤ BMI ≤ 30 kg/m2 at screening.
• Subjects who have been diagnosed by the investigator with subacute cough (course of disease: 3-8 weeks) following respiratory tract infection.
• Subjects who are willing to discontinue previous antitussives at screening.
• Subjects who are willing to discontinue traditional Chinese medicines or Chinese patent medicines at screening.
• Agreement to use at least one effective method of contraception during the study and for 3 months after the final dose.
• Subjects who agree not to donate any sperm or egg during the study and for 3 months after the final dose.
• Subjects who agree to sign the ICF and comply with all aspects of the study.

You may not qualify if:

• Subjects with SPO2 ≤ 93% or significant polypnoea at rest during screening.
• Subjects who have undergone chest X-ray or CT within 2 weeks before screening and have clinically significant lung lesions as judged by the investigator.
• Subjects with cough and a large amount of thick phlegm that is difficult to expectorate and facing more safety risks in this study as judged by the investigator.
• Subjects with acute respiratory tract infection (such as sputum purulent, pyrexia, white blood cell count increased or neutrophil count increased, and hs-CRP increased) as judged by the investigator at screening.
• Subjects with infection in systems other than the respiratory system requiring systemic anti-infective therapy as judged by the investigator at screening.
• Subjects with a history of chronic sinusitis, rhinitis allergic, seasonal cough and cough variant asthma (CVA), or with a history of systemic skin/mucosa allergy within 8 weeks before screening.
• Subjects with a clear history of lung disorders (such as bronchial asthma, chronic obstructive pulmonary disease, pneumonia interstitial, pulmonary carcinoma and bronchiectasis) and unsuitable for this clinical study as judged by the investigator.
• Subjects with severe or poorly controlled pre-existing diseases of various systems other than the respiratory system (such as liver disorders, chronic kidney disease, severe hematological diseases, chronic cardiac failure congestive \[New York Heart Association (NYHA) Class III/IV\], acute coronary syndrome, nervous system disorders including cerebrovascular and neuromuscular diseases, and metabolic diseases) and unsuitable for this clinical study as judged by the investigator.
• Subjects with clinically significant abnormalities in clinical laboratory tests at screening and unsuitable for this clinical study as judged by the investigator, including but not limited to the following: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), serum total bilirubin (TBIL), and creatinine (Cr) \> 200% × upper limit of normal (ULN).
• History of alcohol or drug abuse in the past year.
• Past or current history of major mental disorders.
• Female subjects who are pregnant or lactating.
• Subjects who are current smokers or have quit smoking within 6 months before screening.
• Subjects who have participated in any other clinical trial within 3 months prior to screening, or are still in the safety washout period (\< 5 half-lives) of the previous clinical trial on the first dosing day in this study, whichever is longer.
• Presence of other factors that may increase the risk to subjects, affect the study results, or interfere with their participation in the whole study process, including but not limited to abnormal vital signs, physical examinations, ECGs and/or clinical laboratory tests, as judged by the investigator.

Sponsors & Collaborators

• Wuhan Createrna Science and Technology Co., Ltd: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

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

Study Officials

• Ting Yang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatment assignment during the the administration and observation period will be kept blinded to participants, investigators, care providers, and outcome assessors if applicable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects were randomized at a ratio of 1:1:1 into QR052107B 100 mg QD, QR052107B 400 mg QD and placebo groups and then entered the administration and observation period.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 10, 2025
• Study Start: June 21, 2023
• Primary Completion: November 22, 2023
• Study Completion: December 25, 2023
• Last Updated: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)