Target- |
MechanismSARS coronavirus 2 ORF1Ab inhibitors [+3] |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date20 Jan 1800 |
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MechanismSARS coronavirus 2 ORF1Ab inhibitors [+1] |
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|
|
Inactive Indication- |
Drug Highest PhaseIND Application |
First Approval Ctry. / Loc.- |
First Approval Date20 Jan 1800 |
An Exploratory Phase I, Randomized, Observer-blind, Active-controlled, Dose-escalation Trial Evaluating the Safety, Tolerability, and Immunogenicity of an Investigational RNA-based SARS-CoV-2 Vaccine in COVID-19 Vaccine Experienced Healthy Adults
This is an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b. Dose 1 will be given observer-blind and Dose 2 open-label.
The trial will use a staggered dosing process schema, i.e., enrollment into the next higher dose level is done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged >55 years will be opened after safety data for participants aged 18-55 years in Cohort 3a has been reviewed. Enrollment into Cohorts 4a and 4b will be opened after safety data for Cohort 3a and 3b has been reviewed.
BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) will be administered co-administered (as a single injection).
In addition, depending upon the observed safety and immunogenicity data, the sponsor may update cohorts to evaluate higher or additional DLs of BNT162b4 in combination with the selected spike-encoding RNA vaccine BNT162b2 Bivalent (original/Omicron BA.4/BA.5) or BNT162b2 Monovalent (OMI XBB.1.5).
100 Clinical Results associated with SARS-CoV-2 ORF1Ab x SARS-CoV-2 N protein
100 Translational Medicine associated with SARS-CoV-2 ORF1Ab x SARS-CoV-2 N protein
0 Patents (Medical) associated with SARS-CoV-2 ORF1Ab x SARS-CoV-2 N protein