Date: 2016-04-07
Type of
information: Initiation of the trial
phase: 1
Announcement: treatment of the first patient
Company: Galapagos (Belgium) Morphosys (Germany)
Product: MOR106
Action
mechanism:
- monoclonal antibody. MOR106 is a human IgG1 monoclonal antibody arising from the alliance initiated by Galapagos and MorphoSys in 2008.
Disease: inflammation
Therapeutic
area: Inflammatory diseases
Country:
Trial
details:
Latest
news:
- • On April 7, 2016, MorphoSys and Galapagos announced that dosing of MOR106, a first-in-class human monoclonal antibody, in healthy volunteers has been initiated in a phase 1 study. MOR106 was jointly discovered by MorphoSys and Galapagos under their collaboration, and has a novel mode of action with potential application in inflammation. The primary objective of the phase 1 study is to evaluate the safety and tolerability of single doses of MOR106. The study is randomized, double-blind, placebo-controlled and conducted in a single center in at least 56 healthy volunteers in Belgium, evaluating single ascending doses (SAD) administered as intravenous infusion. This phase 1 study is characterized by its adaptive design, which enables the initiation of a subsequent multiple ascending dose (MAD) study in patients, depending on the outcome of the SAD study in healthy volunteers.
- The study's secondary objective is to characterize the pharmacokinetic profile of MOR106 as well as monitor the occurrence of anti-drug antibodies as a measure of immunogenicity with MOR106. Topline results of the complete study, including the potential subsequent MAD part in patients, are expected in the second half of 2017.
Is
general: Yes
