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Taking people in ChinaPhase 2

Tests RC1416 injection in moderate to severe COPD

Tests RC1416 injection against placebo in adults with moderate to severe COPD.

Plain-language title generated from the registry record
Registry title: Phase II Study of RC1416 Injection in COPD

Key facts

Where
Anyang, Changchun, Chengdu, Chongqing, Guangzhou, Hangzhou, Hefei, Hohhot, Huizhou, Jiangmen, Jiaozuo, Jiujiang, Lianyungang, Liaocheng, Loudi, Mianyang, Nanjing, Nanning, Nanyang, Pingxiang, Qingdao, Qingyuan, Sanmenxia, Shanghai, Shenyang, Suining, Suzhou, Weifang, Wenzhou, Xiamen, Xinxiang, Xuzhou, Yangzhou, Yichang, Yulin, Zaozhuang, Zibo, Zigong, and Zunyi, ChinaSee the 45 sites
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 85 years old?

Source: NCT07402551, who can take part

Where in China

  • Anyang People's HospitalAnyang, ChinaTaking people
  • The Second Hospital of Jilin UniversityChangchun, ChinaTaking people
  • Chengdu Fifth People's HospitalChengdu, ChinaTaking people
  • The First People's Hospital of Shuangliu District, ChengduChengdu, ChinaNot yet recruiting
  • The Third People's Hospital of Chengdu CityChengdu, ChinaTaking people
  • The Affiliated Bishan Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • Yongchuan Hospital Affiliated to Chongqing Medical UniversityChongqing, ChinaTaking people
  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
  • The First Affiliated Hospital of Jinan UniversityGuangzhou, ChinaTaking people
  • The First People's Hospital of Hangzhou (Westlake University Affiliated The First People's Hospital of Hangzhou)Hangzhou, ChinaNot yet recruiting
  • Anhui Provincial Chest HospitalHefei, ChinaTaking people
  • The Affiliated Hospital of Inner Mongolia Medical UniversityHohhot, ChinaTaking people
  • Huizhou Third People's HospitalHuizhou, ChinaTaking people
  • Jiangmen Central HospitalJiangmen, ChinaTaking people
  • Jiaozuo Second People's HospitalJiaozuo, ChinaTaking people
  • Jiu Jiang NO.1 People's HospitalJiujiang, ChinaTaking people
  • The First People's Hospital of Lianyungang CityLianyungang, ChinaTaking people
  • Liaocheng People's HospitalLiaocheng, ChinaTaking people
  • Loudi Central HospitalLoudi, ChinaTaking people
  • Mianyang Central HospitalMianyang, ChinaTaking people
  • Nanjing First HospitalNanjing, ChinaTaking people
  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
  • Nanyang First People's HospitalNanyang, ChinaTaking people
  • Nanyang Second People's HospitalNanyang, ChinaTaking people
  • People's Hospital of Pingxiang CityPingxiang, ChinaTaking people
  • QingDao Municipal HospitalQingdao, ChinaTaking people
  • Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)Qingyuan, ChinaTaking people
  • Sanmenxia Central HospitalSanmenxia, ChinaTaking people
  • Shanghai Pulmonary HospitalShanghai, ChinaTaking people
  • Shengjing Hospital Of China Medical UniversityShenyang, ChinaTaking people
  • Suining Central HospitalSuining, ChinaTaking people
  • Wan Bei General Hospital of Wanbei Coal power GroupSuzhou, ChinaTaking people
  • The Second People's Hospital of WeifangWeifang, ChinaTaking people
  • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMUWenzhou, ChinaTaking people
  • Zhongshan Hospital Xiamen UniversityXiamen, ChinaTaking people
  • Xinxiang First People's HospitalXinxiang, ChinaTaking people
  • Suining County People's HospitalXuzhou, ChinaNot yet recruiting
  • Xuzhou Central HospitalXuzhou, ChinaTaking people
  • Yangzhou University Affiliated HospitalYangzhou, ChinaTaking people
  • Yichang Central People's HospitalYichang, ChinaTaking people
  • The First people's hospital of YulinYulin, ChinaTaking people
  • Zaozhuang Municipal HospitalZaozhuang, ChinaNot yet recruiting
  • Zibo Municipal HospitalZibo, ChinaTaking people
  • Zigong First People's Hospital Zigong Academy of MedicalsciencesZigong, ChinaTaking people
  • Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Nanjing RegeneCore Biotech Co., Ltd.
Trial code
NCT07402551
Record updated
8 September 2026
Original description
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).Read full original descriptionShow less

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of RC1416 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Inclusion: Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender; Body Mass Index (BMI) ≥ 16 kg/m²; Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening; Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) < 0.7, and post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted value at screening; A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors; A score of ≥ 2 on the modified Medical Research Council (mMRC) dyspnea scale at screening; Medical records or relevant documentation showing ≥ 2 moderate COPD. exacerbations (AECOPD) or ≥ 1 severe AECOPD within the 12 months prior to screening; Medical records or relevant documentation showing receipt of background triple therapy (ICS + LABA + LAMA) for ≥ 3 months prior to randomization; A blood eosinophil count ≥ 150/mm³ (0.15×10⁹/L) at screening.

Exclusion: A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form; Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period; A current diagnosis of asthma or a history of asthma; Presence of other significant pulmonary diseases except COPD as judged by the Investigator; History of malignancy ; Presence of recurrent, chronic, or other active infections at screening; Active hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibody, or positive Treponema pallidum antibody (TP-Ab); Diagnosis of α1-antitrypsin deficiency; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

ClinicalTrials.gov NCT07402551