M2 PHARMA-February 16, 2018-First Patient Enrolled in Mallinckrodt's Safety and Tolerability
Study of Skin Substitute
There were no serious or severe AEs reported and tolerability
was consistent with the Phase 1 healthy volunteer study.
To examine tolerability
based on safety parameters, the research recorded the number of adverse events and changes in various clinical and laboratory parameters, as well as the global evaluation of tolerability
by investigators and subjects, as compared to placebo.
The data show that ADX71149 met the primary objectives of safety and tolerability
The company said its hepatitis C drug candidate showed positive "proof-of-concept" results, while meeting safety and tolerability
goals in an early-stage study.
has initiated enrollment and patient dosing in a multinational, 12-week, double-blind Phase II trial designed to compare the efficacy and tolerability
of CH-1504 against methotrexate (MTX) in rheumatoid arthritis (RA) patients.
and Europe to evaluate the efficacy, dose response, safety and tolerability
of Reverset in treatment- experienced human immunodeficiency virus (HIV) infected patients who are failing their current treatment regimens.
Phase I trials (300 participants) were performed to establish immunogenicity and tolerability
of a range of doses of monovalent HPV L1 vaccines.
Antiviral activity, safety, and tolerability
of a novel, oral small-molecule HIV-1 attachment inhibitor, BMS-488043, in HIV-1-infected subjects, 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004 [abstract 141]
Important considerations include crossclade reactivity (effectiveness in diverse HIV-infected populations), tolerability
, and durability of response.
Positive long-term safety and tolerability
data are now available.
The favorable safety and tolerability
profile observed for arimoclomol in our recent Phase IIa ALS trial, combined with previous and recent animal toxicology results, suggests that we may be able to safely increase the dose without causing significant side effects.