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Developed by 
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Supported by 
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Clulevibart (RB0026)
Developer(s)
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ReYoung Originator
https://www.reyoung.com/s.php/en/
China ReYoung Biology Science & Technology Co., Ltd. |
Drug structure
Structure placeholder
Drug information
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Administration route
Intramuscular
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
Frequency of administration
User acceptance
Dosage
Available dose and strength
to be determined
Maximum dose
to be determined
Recommended dosing regimen
to be determined
Additional comments
Not provided
Dosage link(s)
Not provided
Drug information
Generic name
Brand name
Compound type
Drug class/category
Summary
Approval status
Regulatory authorities
Safety
Efficacy
Evidence Summary
Delivery device(s)
Not provided
Scale-up and manufacturing prospects
Scale-up prospects
Not provided
Tentative equipment list for manufacturing
Not provided
Manufacturing
Not provided
Specific analytical instrument required for characterization of formulation
Not provided
Clinical trials
CTR20243661
Identifier
CTR20243661
Link
https://synapse.patsnap.com/drug/35e518d17b384cd1bd2a3e4e276c675e
Phase
Phase III
Status
Completed
Sponsor
Reyoung
More details
Primary objectives: 1 Effectiveness (Efficacy): To evaluate the effectiveness of RB0026 injection in reducing RSV-induced lower respiratory tract infections (MALRTI) requiring medical intervention within 150 days (D1-D151) after administration compared with placebo in infants who are entering or in their first respiratory syncytial virus (RSV) epidemic season.
Purpose
A multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of RB0026 injection in Chinese premature and full-term infants
Interventions
Not provided
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-10-17
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Neonates
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied populations
Not provided
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Prevention
Key resources
ChiCTR2600123076
Identifier
CHICTR2600123076
Link
https://synapse.patsnap.com/drug/35e518d17b384cd1bd2a3e4e276c675e
Phase
Phase III
Status
Completed
Sponsor
Reyoung
More details
Not provided
Purpose
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of RB0026 Injection in Preterm and Term Infants in China
Interventions
Not provided
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-07-04
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Children
- Neonates
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied populations
Not provided
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Prevention
Key resources
CTR20232147
Identifier
CTR20232147
Link
Not provided
Phase
Phase I/II
Status
Completed
Sponsor
Reyoung
More details
Not provided
Purpose
A multicenter, randomized, double-blind, placebo-controlled, phase Ib/II dose-exploration trial evaluating the safety, tolerability, P preliminary efficacy of RB0026 injection in healthy preterm
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-07-19
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Neonates
- Children
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied populations
Healthy premature infants under one year of age (gestational age ≥29 to <35 weeks) or full-term infants (gestational age ≥35 weeks) with underlying conditions (such as Down syndrome and cleft lip) but without other risk factors are eligible to participate in the trial. Weight ≥ 3.0 Kg at screening Infants in their first RSV infection season at the time of randomized administration (applicable to stage II, not stage Ib)
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
30
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Prevention
Key resources
Excipients
Proprietary excipients used
Not provided
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Not provided
Residual solvents used
Not provided
Patent info
Description
Clulevibart - Full human antibody against respiratory syncytial virus
Brief description
Disclosed are an antibody (preferably a fully human antibody R66) against respiratory syncytical virus RSV, encoding nucleic acids thereof, a vetor and a host cell comprising the same, and a preparation method thereof. Disclosed are also a use of the antibody (preferably a fully human antibody R66) against RSV in the prevention and treatment of RSV-related diseases, and a use of the same in detecting TSV. The above antibody against RSV is preferably a fully human monoclonal antibody. Compared with other animal-derived (e.g., murine) anti-RSV antidodies, the immunogenicity caused by species differences is greatly reduced. With good specificity and affinity, if used for clinic, it will greatly reduce side effects.
Representative patent
WO2017092645
Category
Compound
Patent holder
Eliteimmune Inc.
Exclusivity
Not provided
Expiration date
November 29, 2036
Status
Granted in China, Japan, Australia, the United States, South Korea and patent application is pending in Europe.
Supporting material
Publications
There are no publication
Additional documents
No documents were uploaded
Useful links
There are no additional links