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Clinical Trials in China / NCT07403487
Recruiting Phase 2

Phase II Trial of RC1416 Injection in Asthma

NCT07403487 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing RegeneCore Biotech Co., Ltd.
Phase
Phase 2
Started
2026-03-10
Last updated
2026-09-10

Condition(s) studied

Moderate to Severe Asthma

Investigational drug(s) / intervention(s)

RC1416RC1416 Placebo

RC1416: There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.

RC1416 Placebo: Each subjects will receive the placebo by subcutaneous injection

Study summary

This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female aged 18 and 75 years. * Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines. * Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline. * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits. * Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits. * Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening. * Positive bronchodilator reversibility test. Exclusion Criteria: * Individuals with a known history of allergy to the investigational product or its excipients. * Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function . * Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing. * Used systemic corticosteroids within 1 week prior to screening. * Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing. * Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening. * Underwent major surgery within 8 weeks prior to screening or plans to undergo major surgery during the study period. * With a history of malignancy within the past 5 years . * Active or incompletely treated tuberculosis * Used biologic/systemic immunosuppressant/immunomodulators within 12 weeks or 5 half-lives prior to screening. * Diagnosed active parasitic infection; suspected parasitic infection or high risk of infection. * Abnormal 12-lead electrocardiogram (ECG) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Anqiing Municipal Hospital Anqing Anhui Not Yet Recruiting
Wanbei Coal-Electricity Group General Hospital Suzhou Anhui Recruiting
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting
The Affiliated Yongchuan Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Gansu Provincial People's Hospital Lanzhou Gansu Recruiting
The Third Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
The Affiliated Hospital of North China University of Science and Technology Tangshan Hebei Recruiting
Xingtai People's Hospital Xingtai Hebei Recruiting
The First Affiliated Hospital of Hebei North University Zhangjiakou Hebei Recruiting
Daqing Oilfield General Hospital Daqing Heilongjiang Recruiting
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine Harbin Heilongjiang Recruiting
The Third Affiliated Hospital of Qiqihar Medical University Qiqihar Heilongjiang Recruiting
Anyang People's Hospital Anyang Henan Recruiting
The First Affiliated Hospital of Henan University Kaifeng Henan Recruiting
Sanmenxia Central Hospital Sanmenxia Henan Recruiting
Xinxiang First People's Hospital Xinxiang Henan Recruiting
Yichang Central People's Hospital Yichang Hubei Recruiting
Huhhot First Hospital Hohhot Inner Mongolia Not Yet Recruiting
The Affiliated Hospital of Inner Mongolia Hohhot Inner Mongolia Not Yet Recruiting
Nanjing Jiangning Hospital Nanjing Jiangsu Recruiting
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Recruiting
Xuzhou Mining Group General Hospital Xuzhou Jiangsu Recruiting
Xuzhou Central Hospital Xuzhou Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Jilin Central Hospital Jilin City Jilin Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
The Fourth Affiliated Hospital of China Medical University Shenyang Liaoning Recruiting
Ningxia Hui Autonomous Region People's Hospital Yinchuan Ningxia Recruiting
Xi'an International Medical Center Hospital Xi'an Shaanxi Recruiting
Heze Municipal Hospital Heze Shandong Recruiting
Qilu Second Hospital of Shandong University Jinan Shandong Recruiting
The Affiliated Hospital of Jining Medical University Jining Shandong Recruiting
Qingdao Municipal Hospital Qingdao Shandong Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Recruiting
Zibo Central Hospital Zibo Shandong Recruiting
Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital) Shanghai Shanghai Municipality Recruiting
Yuncheng Central Hospital Yuncheng Shanxi Recruiting
Chengdu Third People's Hospital Chengdu Sichuan Recruiting
Chengdu Fifth People's Hospital Chengdu Sichuan Recruiting

+ 4 more sites — see the full list on the official registry below.

More Nanjing RegeneCore Biotech Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07403487 on ClinicalTrials.gov ↗ ← All trials in China