Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064
Completed
Novartis Pharmaceuticals
Phase 1
This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5
is in health volunteers and part 6 is in subjects with atopic dermatitis.
The purpose of this first-in-human study is to assess the safety and tolerability and
pharmacokinetics (PK) of single and multiple doses of LOU064 both as once and twice daily
oral administration in healthy volunteers and those with atopic diathesis or atopic
dermatitis. This study will also explore the effect of food intake and different drug
substance particle sizes on the in vivo disposition of LOU064 in healthy volunteers to guide
dosing and formulation development for future clinical trials.
The study is registered on CT.Gov with the initiation of part 6 in patients (FPFV in April
2019).
Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
Completed
Novartis Pharmaceuticals
Phase 2
This is a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding
study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria
(CSU) patients inadequately controlled by H1-antihistamines
Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients
Terminated
Novartis Pharmaceuticals
Phase 2
This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with
inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064
100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of
budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).
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