Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGAlpha-0261
Oral, tablet
OTHERPlacebo
Oral, tablet
Sponsors
AlphaMol Science Ltd. (Shanghai)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent must be obtained before any assessment is performed.(Part 1 and Part 2) * Aged ≥ 18 and ≤ 75, male or female (Part 1). * Diagnosed with CSU prior to screening at least 6 months. (Part 1) * Received stable second-generation H1 antihistamine therapy for at least 2 weeks before randomization, and is willing to maintain the stable treatment regimen throughout the study treatment period. (Part 1) * Aged ≥ 18 and ≤ 55, male or female (Part 2). * Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2. (Part 2) * In general good health. (Part 2)
Exclusion criteria
* Inducible urticaria with identifiable triggers, including dermographism, cold contact urticaria, heat contact urticaria, solar urticaria, pressure urticaria, delayed pressure urticaria, aquagenic urticaria, cholinergic urticaria, or contact urticaria. (Part 1) * Other chronic pruritic skin diseases that may affect the assessment of study outcomes, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. (Part 1) * Other conditions that may cause urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria. (Part 1) * Have a history of any severe allergic reaction or anaphylaxis. (Part 2) * Any condition, which in the investigator's opinion might jeopardize articipant's safety or compliance with the protocol. (Part 2) * Have clinically significant abnormalities on clinical laboratory results. (Part 2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of treatment emergent adverse events | Part 1: approximately 6 weeks Part 2: approximately 1 week | Incidence, severity and relationship to study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1) | From enrollment to the end of treatment at 4 weeks. | 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. |
| Pharmacokinetics Cmax (Part 2) | From enrollment to end of follow-up visit, up to approximately 1 week. | Cmax: Maximum Plasma Concentration |
| Pharmacokinetics AUC (part 2) | From enrollment to end of follow-up visit, up to approximately 1 week. | AUC: Area Under the Concentration-time Curve |
Countries
China
Contacts
CONTACTHuang Yu, PhD
Outcome results
None listed