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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date26 Mar 2021 |
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MechanismRespiratory syncytial virus F protein inhibitors |
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Active Indication- |
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
FANTASY-A Randomised, Double-Blind, 3-arm Parallel Study to Compare the Pharmacokinetics, Safety, Immunogenicity and Tolerability of MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis®, Administered as a Single Dose Intramuscular Injection in Healthy Volunteers.
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU Synagis® in healthy subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
A Randomised, Double-blind, Parallel, Multicentre, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) Versus Prolia® (EU-sourced) in Postmenopausal Women With Osteoporosis (SIMBA Study)
This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis
A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Proposed Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
100 Clinical Results associated with mAbxience Research SL
0 Patents (Medical) associated with mAbxience Research SL
100 Deals associated with mAbxience Research SL
100 Translational Medicine associated with mAbxience Research SL