A Phase Ib Study of RC1416 Injection

NCT06911866 | Completed Phase 1 FDA Drug

• 1 other identifier: RJK-RC1416-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 16

Brief Summary

This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RC1416 injection in patients with moderate to severe asthma.

Conditions

Moderate to Severe Asthma

Outcome Measures

Primary Outcomes (6)

• AE

  incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0

  up to 141 days

• SAE

  incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0

  up to 141 days

• Vital Signs

  number of praticipants with clinically notable Vital Signs according to CTCAE V5.0

  up to 141 days

• Laboratory Tests

  number of praticipants with clinically Laboratory Tests Values according to CTCAE V5.0

  up to 141 days

• ECG

  number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0

  up to 141 days

• Injection Site Reaction

  number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0

  up to 85 days

Secondary Outcomes (13)

• Cmax

  up to 141 days

• AUC0-t

  up to 141 days

• AUC0-inf

  up to 141 days

• Anti-Drug antibody (ADA)

  up to 141 days

• Tmax

  up to 141 days

Study Arms (2)

RC1416

EXPERIMENTAL

Drug: RC1416

Placebo

PLACEBO COMPARATOR

Drug: RC1416 Placebo

Interventions

RC1416 DRUG

there are four doses(200mg-400mg) in this part. Each subjects will receive the drug once by subcutaneous injection.

RC1416

RC1416 Placebo DRUG

Each subjects will receive the placebo once by subcutaneous injection.

Placebo

Eligibility Criteria

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

You may qualify if:

• The subject fully understands the purpose, nature, methods and potential adverse events of the trial and voluntarily signs the informed consent form (ICF);
• Male or female patients aged ≥18 and ≤75 years at the time of ICF signing;
• The subject has been diagnosed with asthma for at least one year;
• The subject has been treated with medium to high-dose inhaled corticosteroids (ICS) (e.g.,fluticasone propionate ≥ 250 μg daily or equivalent ICS dose) in combination with at least one additional controller medication \[such as long-acting β2 receptor agonists (LABA), long-acting anticholinergic drugs (LAMA), leukotriene receptor antagonists (LTRA), or sustained-release theophylline\] for ≥ 3 months prior to ICF signing, with a stable dosing for ≥ 1 month before randomization;
• ACQ-6 score \> 1.5 or ACT score \< 20 ;
• Pre-bronchodilator FEV1 ≤ 80% of predicted value at screening;
• Positive objective tests for variable airflow obstruction within one year before randomization or during the screening period (including bronchodilation test, bronchial provocation test or peak expiratory flow variability, etc.).
• The subject agrees to take effective contraceptive measures (as specified in the protocol) from the time of ICF signing until 6 months post-treatment.

You may not qualify if:

• Based on the investigator's judgment,Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may significantly impair lung function (such as atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, bronchiectasis, emphysema, etc.) ;
• Subjects who had required at least one systemic glucocorticoid treatment due to asthma exacerbation or other reasons, or who had been hospitalized or treated emergency department due to asthma exacerbation within one month before administration;
• Subjects with a history of near-fatal asthma requiring endotracheal intubation and mechanical ventilation;
• Subjects who are Excessive dependence on short-acting β-agonists (SABA) (\>10-12 puffs per day) , especially use more than one vial of salbutamol (or equivalent) per month;
• Subjects who used non-selective β-blockers within 1 month before screening until randomization;
• Subjects with pulmonary or other infection and oral or intravenous antibiotics or antifungal or antiviral drugs within one month before administration; Subjects have need local antibiotic or antiviral treatment within 7 days before screening;Subjects with a history of recurrent infections (≥3 times per year) and underlying diseases that predispose to infection; Subjects with a history of disseminated herpes simplex infection or recurrent (\>1 time) or disseminated herpes zoster; Subjects with a history of opportunistic infections;
• Subjects who underwent major surgery within 6 months prior to screening or planned major surgery during the trial.
• Subjects who have suffered form malignancy within 5 years,except:
• Subjects with cervical carcinoma in situ that has been completely resected and has no evidence of recurrence or metastasis for at least 3 years;
• Subjects with basal cell or squamous cell carcinoma that have been completely resected and have no recurrence for at least 3 years;
• Subjects with a history of cancer who have had complete remission of their malignant tumors for at least 5 years at the time of screening and have no anti-tumor treatment;
• Currently receiving or having received any of the prohibited drugs or treatments in this trial within the following time frames :
• Live vaccines, attenuated live vaccines, or adenovirus vector vaccines within 3 months prior to screening or plan to receive such vaccines during the trial;
• Any of the following drugs within 3 months or 5 half-lives (whichever is longer) prior to screening: IL-4Rα antagonists, IL-5/interleukin-5 receptor (IL-5R) antagonists, anti-IgE monoclonal antibodies, anti-TSLP antibodies, etc.;
• Bronchial thermoplasty within 3 years prior to screening;

Sponsors & Collaborators

• Nanjing RegeneCore Biotech Co., Ltd.: lead

Study Sites (16)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

The First Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

Hebei Petro China Centre Hospital

Langfang, Hebei, China

Location

Hebei Province Hospital of Chinese Medicine

Shijiazhuang, Hebei, China

Location

Nanyang Central Hospital

Nanyang, Henan, China

Location

Xinxiang First People's Hospital

Xinxiang, Henan, China

Location

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

Jining NO.1 people's hospital

Jining, Shandong, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, China

Location

Zibo Municipal Hospital

Zibo, Shandong, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: October 25, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: January 30, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)