- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067490
A Phase I Study of RC1416 Injection
September 27, 2023 updated by: Nanjing RegeneCore Biotech Co., Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
48
Phase
- Phase 1
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
- Name: Guo Qian
- Phone Number: +86-025-58608860
- Email: guoqian@regenecore.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- China-Japan Friendship Hospital
-
Contact:
- Li J Tong, Doctor
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RC1416
RC1416(SAD),single ascending (25mg-600mg) of RC1416 by subcutaneous injection
|
RC1416(SAD),there are six doses(25mg-600mg) in this part.
Each subjects will receive the drug once by subcutaneous injection.
Other Names:
|
Placebo Comparator: Placebo
Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.
|
Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: up to 92 days
|
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
|
up to 92 days
|
Vital Signs
Time Frame: up to 92 days
|
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
|
up to 92 days
|
Laboratory Tests
Time Frame: up to 92 days
|
number of praticipants with clinically notable Laboratory Tests according to CTCAE V5.0
|
up to 92 days
|
ECG
Time Frame: up to 92 days
|
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
|
up to 92 days
|
Injection Site Reaction
Time Frame: up to 4 days
|
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
|
up to 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics-Cmax
Time Frame: up to 92 days
|
maximum serum concentration
|
up to 92 days
|
Pharmacokinetics-AUC 0-t
Time Frame: up to 92 days
|
area under the concentration-time curve (AUC) from administration to the last measurable concentration
|
up to 92 days
|
Pharmacokinetics-AUC 0-inf
Time Frame: up to 92 days
|
AUC extrapolated to infinitymeasurable concentration
|
up to 92 days
|
Anti-Drug antibody (ADA)
Time Frame: up to 92 days
|
number and percentage of subjects tested ADA positive
|
up to 92 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Li J Tong, Doctor, China-Japan Friendship Hospital
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)
July 3, 2023
Primary Completion (Estimated)
May 20, 2024
Study Completion (Estimated)
August 18, 2024
Study Registration Dates
First Submitted
September 12, 2023
First Submitted That Met QC Criteria
September 27, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- NJRJK-RC1416-Ia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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