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
China
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
Genders
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
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Prevention
Key resources
Not provided
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
China
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
Genders
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
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Prevention
Key resources
Not provided
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
RS-0026
Countries
China
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
Genders
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
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Prevention
Key resources
Not provided
