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Phase II Trial of RC1416 Injection in Asthma | Clinical Trials | Clareo Health

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Phase II Trial of RC1416 Injection in Asthma

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

NCT07403487•Nanjing RegeneCore Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 month 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.
+2 more criteria

Locations (45)

Wanbei Coal-Electricity Group General Hospital

Suzhou, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Liuzhou Workers' Hospital

Liuchow, Guangxi, China

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Affiliated Hospital of North China University of Science and Technology

Tangshan, Hebei, China

Xingtai People's Hospital

Xingtai, Hebei, China

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Key Dates

Start Date

March 10, 2026

Primary Completion Date

October 25, 2027

Completion Date

February 28, 2028

Last Updated

February 11, 2026

Enrollment

195

ESTIMATED participants

Conditions

Moderate to Severe Asthma

Interventions

RC1416

DRUG

RC1416 Placebo

DRUG

Contacts

Guo Qian

CONTACT

+86-025-58608860 guoqian@regenecore.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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