Healthy VolunteersPhase 1NCT06067490
A Phase I Study of RC1416 Injection
A Phase 1 study testing RC1416(SAD) in people with Healthy Volunteers, run by Nanjing RegeneCore Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RC1416(SAD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2023to 14 May 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 50 years(including the boundary value)，Chinese.
- Male Weight of 50 kg to 90 kg，femal weight of 40kg to 90kg, and BMI of 19.0 to 28.0 kg/m2 (including the boundary value).
- Subject have no fertility, sperm/egg donation plan for at least 6 months from the signing of the informed consent to the end of the treatment, and voluntarily takes medically recognized effective non-drug contraceptive measures (including his partner) during the trial.
Who cannot join
- Have participated in clinical trials of drugs in other trials within 3 months prior to screening .
- With clinically significant investigator-identified abnormalities of the cardiovascular, respiratory, digestive, endocrine systems (e.g., diabetes), nervous/mental systems, blood, and lymphatic systems (immune deficiency), and musculoskeletal systems.
- With clinically significant infectious disease (e.g., cellulitis, abscess, or systemic infection (e.g., sepsis), or history of clinically significant opportunistic infection (e.g.,invasive candidiasis or pneumocystis pneumonia) within 3 months before to screening.
- With a history of active tuberculosis or the presence of latent tuberculosis infection or active tuberculosis indicated by any current symptoms, signs or laboratory tests.
- Have an allergic constitution, history of allergy to the test drug ingredient or to any drug or food or pollen.
- Received chemotherapy, radiotherapy, immunosuppressive therapy, or high-dose corticosteroid treatment within 5 years before signing the informed consent.
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- Use of any prescription, OTC, traditional Chinese medicine, vitamin or health product within 1 month prior to screening;
- Received live or attenuated vaccines within 1 month or have any vaccination schedule during the clinical trial.
- Had surgery within 6 months prior to screening or planned surgery during the trial.
- Have difficulty with venous blood collection, or subjects who faint at the sight of blood or a needle, or have difficulty with subcutaneous administration.
- Have lost or donated blood for more than 400 mL(not including menstrual blood loss )or received blood transfusion or using blood products within 3 months before signing informed consent or planning to donate blood during the study or within 1 month after the trial.
- Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 250 mL per cup) within 6 months prior to screening.
- Have consumed any beverage or food containing grapefruit or caffeine (such as grapefruit juice, coffee, strong tea, chocolate, caffeinated carbonated beverages, cola, cocoa, etc.) in the 48 hours prior to screening.
- Have special dietary requirements and cannot comply with a unified diet.
- Smoked ≥5 cigarettes per day within 3 months prior to screening or or could not guarantee to quit smoking during the trial.
- Regularly drank alcohol 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 could not abstinence during the trial; Or a positive alcohol breath test;
- With previous history of drug abuse/drug use; Or test positive for drug abuse screening (including THC, morphine, ketamine, methamphetamine, benzodiazepines, cocaine);
- Pregnant or lactating women, or positive blood pregnancy test results;
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus (HIV) antigen-antibody combined detection, syphilis treponema specific antibody at the screening visit.
- Subjects with the results of physical examination, vital signs, laboratory examination and other auxiliary examinations (chest imaging, abdominal B-ultrasonography, 12-lead electrocardiogram, etc.) were judged by the investigator as abnormal and clinically significant during the screening period.
- The investigators considered that subjects were not suitable for this clinical trial for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
China-japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andImmunogenicity of RC1416 Injection Via Subcutaneous Administration in Healthy Adult Volunteers.
This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.
Read the 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 48 healthy adult subjects will be enrolled in six groups to access the safety and tolerability of single subcutaneous injection of RC1416 in healthy adult subjects.
- Conditions
- Healthy Volunteers
- Being tested
- RC1416(SAD), Placebo(SAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC1416(SAD)Drug
Also called RC1416
RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection.
Placebo(SAD)Drug
Also called RC1416 Placebo
Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| RC1416 | Experimental | RC1416(SAD),single ascending (25mg-600mg) of RC1416 by subcutaneous injection Receives: Drug: RC1416(SAD) |
| Placebo | Placebo comparator | Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection. Receives: Drug: Placebo(SAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
Measured: up to 92 days
Vital Signs
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
Measured: up to 92 days
Laboratory Tests
number of praticipants with clinically notable Laboratory Tests according to CTCAE V5.0
Measured: up to 92 days
ECG
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
Measured: up to 92 days
Injection Site Reaction
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
Measured: up to 4 days
Secondary outcomes (4)
Pharmacokinetics-Cmax
maximum serum concentration
Measured: up to 92 days
Pharmacokinetics-AUC 0-t
area under the concentration-time curve (AUC) from administration to the last measurable concentration
Measured: up to 92 days
Pharmacokinetics-AUC 0-inf
AUC extrapolated to infinitymeasurable concentration
Measured: up to 92 days
Anti-Drug antibody (ADA)
number and percentage of subjects tested ADA positive
Measured: up to 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start29 Jun 2023
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing RegeneCore Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li J Tong, Doctor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067490
- Sponsor's protocol ID
- NJRJK-RC1416-Ia
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andImmunogenicity of RC1416 Injection Via Subcutaneous Administration in Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT06067490
- Acronym / sponsor ID
- NJRJK-RC1416-Ia
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nanjing RegeneCore Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 5 Oct 2023 (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 I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.
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 48 healthy adult subjects will be enrolled in six groups to access the safety and tolerability of single subcutaneous injection of RC1416 in healthy adult subjects.
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(SAD)RC1416(SAD),single ascending (25mg-600mg) of RC1416 by subcutaneous injection |
| Placebo | Placebo comparator | Drug: Placebo(SAD)Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female aged 18 to 50 years(including the boundary value)，Chinese.
- Male Weight of 50 kg to 90 kg，femal weight of 40kg to 90kg, and BMI of 19.0 to 28.0 kg/m2 (including the boundary value).
- Subject have no fertility, sperm/egg donation plan for at least 6 months from the signing of the informed consent to the end of the treatment, and voluntarily takes medically recognized effective non-drug contraceptive measures (including his partner) during the trial.
Key exclusion criteria (21 listed)
- Have participated in clinical trials of drugs in other trials within 3 months prior to screening .
- With clinically significant investigator-identified abnormalities of the cardiovascular, respiratory, digestive, endocrine systems (e.g., diabetes), nervous/mental systems, blood, and lymphatic systems (immune deficiency), and musculoskeletal systems.
- With clinically significant infectious disease (e.g., cellulitis, abscess, or systemic infection (e.g., sepsis), or history of clinically significant opportunistic infection (e.g.,invasive candidiasis or pneumocystis pneumonia) within 3 months before to screening.
- With a history of active tuberculosis or the presence of latent tuberculosis infection or active tuberculosis indicated by any current symptoms, signs or laboratory tests.
- Have an allergic constitution, history of allergy to the test drug ingredient or to any drug or food or pollen.
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 |
|---|---|---|
| RC1416(SAD)Also: RC1416RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection. | Drug | RC1416 |
| Placebo(SAD)Also: RC1416 PlaceboPlacebo(SAD), Each subjects will receive the placebo once by subcutaneous injection. | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: up to 92 days
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
Vital Signs
Time frame: up to 92 days
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
Laboratory Tests
Time frame: up to 92 days
number of praticipants with clinically notable Laboratory Tests according to CTCAE V5.0
ECG
Time frame: up to 92 days
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
Injection Site Reaction
Time frame: up to 4 days
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
4 secondary outcomes
Pharmacokinetics-Cmax
Time frame: up to 92 days
Pharmacokinetics-AUC 0-t
Time frame: up to 92 days
Pharmacokinetics-AUC 0-inf
Time frame: up to 92 days
Anti-Drug antibody (ADA)
Time frame: up to 92 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 2 Dec 2024.
- 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.
Li J Tong, Doctor principal investigator
China-Japan Friendship Hospital
1 site 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(SAD) in people with Healthy Volunteers, run by Nanjing RegeneCore Biotech Co., Ltd. at 1 site 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 3 inclusion and 21 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Adverse Events (time frame: up to 92 days). The study lists 5 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 2 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.