Moderate to Severe AsthmaPhase 1NCT06911866
A Phase Ib Study of RC1416 Injection
A Phase 1 study testing RC1416 in people with Moderate to Severe Asthma, run by Nanjing RegeneCore Biotech Co., Ltd. at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Asthma
- What is being tested?
- RC1416
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 16 sitesChina
- Study dates
- 25 Oct 2024to 25 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 45Show fewer
- 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;
- Allergen immunotherapy within 3 months prior to screening or plan to receive such treatments during the trial;
- Drugs that affect immunity within 3 months or 5 half-lives (whichever is longer) prior to screening, including but not limited to systemic immunosuppressants/immunomodulatory drugs (including but not limited to methotrexate, cyclosporine, etc.);
- Montelukast within 2 weeks prior to screening;
- Immunoglobulin products within 3 months prior to screening;
- Traditional Chinese medicine or herbal products that affect bronchospasm and/or lung function within 1 month prior to screening.
- Subjects who have received any investigational drug or participated in other clinical trials or medical research activities within 3 months or 5 half-lives (whichever is longer) before screening, or plan to participate in other drug or medical device clinical trials during the trial; except subjects who have only signed the ICF and participated in the screening of clinical trials but did not receive clinical trial treatment or enrollment within 3 months before the first dose.
- Subjects who have donated blood or lost blood ≥ 400 mL (excluding menstrual blood loss), or received blood transfusion or used blood products within 3 months before screening, or plan to donate blood during the study or within 1 month after the end of the trial.
- Current smokers or subjects who quit smoking within 6 months before screening, or previous smokers who quit smoking more than 6 months at screening with a smoking history > 10 pack-years (pack-years = number of packs smoked per day × number of years of smoking, 20 cigarettes per pack), or who cannot quit smoking during the trial.
- Subjects with known to be allergy to the excipients or ingredients of this product, or have had severe drug or food allergic reactions in the past.
- With any psychological disorders or neurological/psychiatric disorders confirmed by the investigator.
- Subjects who have difficulty with venous blood collection,or are afraid of needles or blood, or those who have difficulty with subcutaneous injection administration.
- Any of the following abnormal in laboratory test results at screening or baseline:
- Hemoglobin < 90 g/L;
- Platelet count < 100 × 109/L;
- Absolute neutrophil count (ANC) < 1.2 × 109/L;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN (upper limit of normal);
- Serum creatinine > 1.5 × ULN;
- Total bilirubin > 1.5 × ULN;
- Other laboratory test results abnormalities are clinically significant, and the investigator judge that the subject are unsuitable for enrollment.
- Subject with clinically significant abnormalities in the 12-lead ECG at screening or baseline as judged by the investigator , or prolonged QTc ( QTcF interval >450 ms for males and >470 ms for females, Corrected by Fridericia，s formula), or a history of long QT syndrome.
- Any one of infectious disease screening indicators meets the following criteria at screening:
- According to the judgment of the investigator, there is vidence of active tuberculosis or a history of active tuberculosis without appropriate treatment, and screening results suggest the possibility of latent tuberculosis infection as judged by the investigator;
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and hepatitis B virus deoxyribonucleic acid (HBV DNA) exceeds the detection limit;
- Hepatitis C antibody (HCVAb) positive and hepatitis C virus ribonucleic acid (HCV RNA) exceeds the detection limit;
- Positive for Treponema pallidum (Tp) antibody;
- Positive for human immunodeficiency virus antigen (HIVAg) or human immunodeficiency virus antibody (HIVAb).
- Subject with previous history of drug abuse/drug use；
- Subject with a history of alcoholism within 6 months prior to screening[(i.e., more than 14 standard units per week for women and more than 21 standard units per week for men (1 standard unit containing 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) ]or those who cannot abstinence during the trial;
- Pregnant or lactating women, or those with a positive pregnancy test result;
- Other situations that the investigator judged are unsuitable for participating in this trial
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Peking University Shougang Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Jining NO.1 people's hospital
Jining, Shandong
Hebei Petro China Centre Hospital
Langfang, Hebei
Liaocheng People's Hospital
Liaocheng, Shandong
Nanjing First Hospital
Nanjing, Jiangsu
Nanyang Central Hospital
Nanyang, Henan
Shenzhen People's Hospital
Shenzhen, Guangdong
Hebei Province Hospital of Chinese Medicine
Shijiazhuang, Hebei
Shanxi Bethune Hospital
Taiyuan, Shanxi
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xinxiang First People's Hospital
Xinxiang, Henan
Zibo Municipal Hospital
Zibo, Shandong
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of RC1416 Injection in Patients With Moderate to Severe Asthma
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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, ascending dose Phase Ib clinical study. RC1416 is a bispecific antibodies .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 40 patients with moderate to severe asthma will be enrolled in 4 groups to access the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of RC1416 injection.
- Conditions
- Moderate to Severe Asthma
- Being tested
- RC1416, RC1416 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC1416Drug
there are four doses(200mg-400mg) in this part. Each subjects will receive the drug once by subcutaneous injection.
RC1416 PlaceboDrug
Each subjects will receive the placebo once by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| RC1416 | Experimental | Not described Receives: Drug: RC1416 |
| Placebo | Placebo comparator | Not described Receives: Drug: RC1416 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
Measured: up to 141 days
SAE
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
Measured: up to 141 days
Vital Signs
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
Measured: up to 141 days
Laboratory Tests
number of praticipants with clinically Laboratory Tests Values according to CTCAE V5.0
Measured: up to 141 days
ECG
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
Measured: up to 141 days
Injection Site Reaction
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
Measured: up to 85 days
Secondary outcomes (13)
Cmax
maximum serum concentration
Measured: up to 141 days
AUC0-t
AUC extrapolated to infinitymeasurable concentration
Measured: up to 141 days
AUC0-inf
area under the concentration-time curve (AUC) from administration to the last measurable concentration
Measured: up to 141 days
Anti-Drug antibody (ADA)
number and percentage of subjects tested ADA positive
Measured: up to 141 days
Tmax
time to reach maximum concentration
Measured: up to 141 days
t1/2
the terminal elimination half-life
Measured: up to 141 days
MRT
mean residence time
Measured: up to 141 days
λz
elimination rate constant
Measured: up to 141 days
CL/F
apparent clearance
Measured: up to 141 days
Vz/F
apparent volume of distribution
Measured: up to 141 days
Change from baseline in fractional exhaled nitric oxide (FeNO)
Preliminary effectiveness indicators
Measured: up to 141 days
Change from baseline in total IgE (immunoglobulin E), human thymus and activation-regulated chemokine (TARC)
Preliminary effectiveness indicators
Measured: up to 141 days
Change from baseline in blood eosinophil (EOS) count, free or bound IL-5 and total IL-5, and free IL-4 and IL-13 levels
Preliminary effectiveness indicators
Measured: up to 141 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start25 Oct 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing RegeneCore Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911866
- Sponsor's protocol ID
- RJK-RC1416-102
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of RC1416 Injection in Patients With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT06911866
- Acronym / sponsor ID
- RJK-RC1416-102
- Conditions
- Moderate to Severe Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nanjing RegeneCore Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled, ascending dose Phase Ib clinical study. RC1416 is a bispecific antibodies .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 40 patients with moderate to severe asthma will be enrolled in 4 groups to access the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of RC1416 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC1416 | Experimental | Drug: RC1416 |
| Placebo | Placebo comparator | Drug: RC1416 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ;
Key exclusion criteria (45 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC1416there are four doses(200mg-400mg) in this part. Each subjects will receive the drug once by subcutaneous injection. | Drug | RC1416 |
| RC1416 PlaceboEach subjects will receive the placebo once by subcutaneous injection. | Drug | Placebo |
Primary outcome
AE
Time frame: up to 141 days
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
SAE
Time frame: up to 141 days
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
Vital Signs
Time frame: up to 141 days
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
Laboratory Tests
Time frame: up to 141 days
number of praticipants with clinically Laboratory Tests Values according to CTCAE V5.0
ECG
Time frame: up to 141 days
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
Injection Site Reaction
Time frame: up to 85 days
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
13 secondary outcomes
Cmax
Time frame: up to 141 days
AUC0-t
Time frame: up to 141 days
AUC0-inf
Time frame: up to 141 days
Anti-Drug antibody (ADA)
Time frame: up to 141 days
Tmax
Time frame: up to 141 days
t1/2
Time frame: up to 141 days
MRT
Time frame: up to 141 days
λz
Time frame: up to 141 days
CL/F
Time frame: up to 141 days
Vz/F
Time frame: up to 141 days
Change from baseline in fractional exhaled nitric oxide (FeNO)
Time frame: up to 141 days
Change from baseline in total IgE (immunoglobulin E), human thymus and activation-regulated chemokine (TARC)
Time frame: up to 141 days
Change from baseline in blood eosinophil (EOS) count, free or bound IL-5 and total IL-5, and free IL-4 and IL-13 levels
Time frame: up to 141 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC1416 in people with Moderate to Severe Asthma, run by Nanjing RegeneCore Biotech Co., Ltd. at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: up to 141 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.