This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with chronic spontaneous urticaria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
48
Oral, tablet
Oral, tablet
Peking University People's Hospital
Beijing, Beijing Municipality, China
Frequency of treatment emergent adverse events
Incidence, severity and relationship to study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Time frame: Part 1: approximately 6 weeks Part 2: approximately 1 week
Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1)
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.
Time frame: From enrollment to the end of treatment at 4 weeks.
Pharmacokinetics Cmax (Part 2)
Cmax: Maximum Plasma Concentration
Time frame: From enrollment to end of follow-up visit, up to approximately 1 week.
Pharmacokinetics AUC (part 2)
AUC: Area Under the Concentration-time Curve
Time frame: From enrollment to end of follow-up visit, up to approximately 1 week.
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