5 results
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
The primary objective of the study is to evaluate the safety, tolerability, PK, and PD of AL002 administered in single ascending doses in healthy participants and multiple doses in participants with mild to moderate AD.
This drug-drug interaction (DDI) study is being conducted to determine if there is a pharmacokinetic (PK) interaction between trametinib and the components of combination oral contraceptives (OCs), norethindrone (NE) and ethinyl estradiol (EE).…
The primary objectives of this add-on Phase 2 LTE study (see Table 1) are to evaluate the long-term safety and tolerability of IMP at three possible doses (ie, 15 mg/kg, 40 mg/kg, and 60 mg/kg) and to assess the effect of dose titration on the…
To evaluate the efficacy of AL002 in participants with Early AD in delaying disease progression compared to standard of care