Phase II Trial of RC1416 Injection in Asthma

September 9, 2026 updated by: Nanjing RegeneCore Biotech Co., Ltd.

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of RC1416 Injection in Adult Patients With Moderate to Severe Asthma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 195 severe uncontrolled asthma subjects will be enrolled in three groups to access the efficacy and safety of RC1416.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Anqing, Anhui, China, 246004
        • Not yet recruiting
        • Anqiing Municipal Hospital
        • Contact:
          • Phone Number: 0556-5223968
      • Suzhou, Anhui, China, 234000
        • Recruiting
        • Wanbei Coal-Electricity Group General Hospital
        • Contact:
          • Jiang Hui
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Yang Ting
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 402160
        • Recruiting
        • The Affiliated Yongchuan Hospital of Chongqing Medical University
        • Contact:
          • Zhang tie feng
          • Phone Number: 023-85382120
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial People's Hospital
        • Contact:
          • Zhang Hong
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • The Third Hospital of Hebei Medical University
        • Contact:
          • Zhao Yun Xia
      • Tangshan, Hebei, China, 063000
        • Recruiting
        • The Affiliated Hospital of North China University of Science and Technology
        • Contact:
          • Yu Chang Li
      • Xingtai, Hebei, China, 054001
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
          • Gao Zhi Guo
      • Zhangjiakou, Hebei, China, 075000
        • Recruiting
        • The First Affiliated Hospital of Hebei North University
        • Contact:
          • Liu Jian Hua
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Recruiting
        • Daqing Oilfield General Hospital
        • Contact:
          • Li Li
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
        • Contact:
          • Yang Shan Jun
      • Qiqihar, Heilongjiang, China, 161000
        • Recruiting
        • The Third Affiliated Hospital of Qiqihar Medical University
        • Contact:
          • jiang Yun Fei
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang People's Hospital
        • Contact:
          • Jia Ming Yong
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • The First Affiliated Hospital of Henan University
        • Contact:
          • Huang Zhi Ang
      • Sanmenxia, Henan, China, 472000
        • Recruiting
        • Sanmenxia Central Hospital
        • Contact:
          • Liu Kuan
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • Xinxiang First People's Hospital
        • Contact:
          • Li Rong Kai
    • Hubei
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Central People's Hospital
        • Contact:
          • Xiong Xiao Qi
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010020
        • Not yet recruiting
        • Huhhot First Hospital
        • Contact:
          • Song fei fang
          • Phone Number: 0471-5281222
      • Hohhot, Inner Mongolia, China, 010030
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia
        • Contact:
          • Gao jun zhen
          • Phone Number: 0471-3451027
    • Jiangsu
      • Nanjing, Jiangsu, China, 211100
        • Recruiting
        • Nanjing Jiangning Hospital
        • Contact:
          • Zhang Xiu Wei
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Zhang Wen Hui
      • Xuzhou, Jiangsu, China, 221009
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
          • Wu yan min
          • Phone Number: 0516-83956108
      • Xuzhou, Jiangsu, China, 221006
        • Recruiting
        • Xuzhou Mining Group General Hospital
        • Contact:
          • Zhao jie
          • Phone Number: 0516-85326063
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Zuo Wei
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Guo Li Ping
      • Jilin City, Jilin, China, 132011
        • Recruiting
        • Jilin Central Hospital
        • Contact:
          • Wang Yu Hong
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Zhao Li
      • Shenyang, Liaoning, China, 110031
        • Recruiting
        • The Fourth Affiliated Hospital of China Medical University
        • Contact:
          • Gu xiiu
          • Phone Number: 024-31365555
    • Ningxia
      • Yinchuan, Ningxia, China, 750002
        • Recruiting
        • Ningxia Hui Autonomous Region People's Hospital
        • Contact:
          • Zhuan Bing
    • Shaanxi
      • Xi'an, Shaanxi, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
          • Fu En Qing
    • Shandong
      • Heze, Shandong, China, 274031
        • Recruiting
        • Heze Municipal Hospital
        • Contact:
          • Liu Xun Chao
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Qilu Second Hospital of Shandong University
        • Contact:
          • Xu Shao Hua
      • Jining, Shandong, China, 272029
        • Recruiting
        • The Affiliated Hospital of Jining Medical University
        • Contact:
          • jiang Bo
      • Qingdao, Shandong, China, 266011
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
          • Han Wei
      • Yantai, Shandong, China, 264000
        • Recruiting
        • Yantai YuHuangDing Hospital
        • Contact:
          • Zou Shen Chun
      • Zibo, Shandong, China, 255036
        • Recruiting
        • Zibo Central Hospital
        • Contact:
          • Yin Xin Da
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital)
        • Contact:
          • Guo Jian
    • Shanxi
      • Yuncheng, Shanxi, China, 044000
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
          • Zhang Hai Xia
    • Sichuan
      • Chengdu, Sichuan, China, 611130
        • Recruiting
        • Chengdu Fifth People's Hospital
        • Contact:
          • Liu Xiao
      • Chengdu, Sichuan, China, 610031
        • Recruiting
        • Chengdu Third People's Hospital
        • Contact:
          • Li Guo Ping
      • Mianyang, Sichuan, China, 621000
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
          • Xu Wei Guo
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Affiliated Hangzhou First People's Hospital
        • Contact:
          • Wang li ming
          • Phone Number: 0571-56005600
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
          • Ma hong ying
          • Phone Number: 0574-87085588
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Wu Li Qin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RC1416
Drug: RC1416
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
Placebo Comparator: RC1416 Placebo
Drug: RC1416 Placebo
Each subjects will receive the placebo by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)
Time Frame: During 32 weeks
Mean change from baseline in Pre-BD forced expiratory volume in 1 Second (FEV1)
During 32 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severe asthma exacerbation
Time Frame: During 32 weeks
Severe asthma exacerbation events, Time to the first asthma exacerbation
During 32 weeks
Pre-BD FEV1
Time Frame: During 32 weeks
During 32 weeks
Morning and evening peak expiratory flow (PEF)
Time Frame: During 32 weeks
Mean change from baseline of absolute value and percentage
During 32 weeks
forced vital capacity (FVC)
Time Frame: During 32 weeks
Mean change from baseline of absolute value and percentage
During 32 weeks
Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD)
Time Frame: During 32 weeks
Mean change from baseline of absolute value and percentage
During 32 weeks
Asthma loss of control (LOAC)
Time Frame: During 32 weeks
Asthma loss of control (LOAC) events, Time to the first Asthma loss of control
During 32 weeks
Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit
Time Frame: During 32 weeks
Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit events
During 32 weeks
Asthma Control Questionnaire-6 (ACQ-6) score
Time Frame: During 32 weeks
Mean change Mean change from baseline. The proportion of trial participants with a reduction of ≥0.5 points from baseline
During 32 weeks
Asthma Quality of Life Questionnaire (AQLQ-S) score
Time Frame: During 32 weeks
Mean change from baseline
During 32 weeks
weekly Asthma Symptom Diary (ASD) score
Time Frame: During 32 weeks
Mean change in mean weekly from baseline
During 32 weeks
Rescue medication
Time Frame: During 32 weeks
Mean change in mean weekly from baseline
During 32 weeks
Adverse Events
Time Frame: During 32 weeks
During 32 weeks
Pharmacokinetics
Time Frame: During 32 weeks
trough concentration
During 32 weeks
Pharmacodynamics
Time Frame: During 32 weeks
mean changes of Pharmacodynamic Parameter from baseline
During 32 weeks
Anti-Drug antibody
Time Frame: During 32 weeks
number and percentage of subjects tested ADA positive
During 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing RegeneCore Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RJK-RC1416-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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