Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alpha-0261, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria (CSU), Healthy Volunteers. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Oral Doses of Alpha-0261 Tablets in Patients With Chronic Spontaneous Urticaria, and the Effect of Food in Healthy Participants.
Overview
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
- Drug Alpha-0261
Oral, tablet - Other Placebo
Oral, tablet
Primary outcome measures
- Frequency of treatment emergent adverse events [Time frame: Part 1: approximately 6 weeks Part 2: approximately 1 week]
Secondary outcome measures (3)
- Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1) [Time frame: From enrollment to the end of treatment at 4 weeks.]
- Pharmacokinetics Cmax (Part 2) [Time frame: From enrollment to end of follow-up visit, up to approximately 1 week.]
- Pharmacokinetics AUC (part 2) [Time frame: From enrollment to end of follow-up visit, up to approximately 1 week.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07684560 · Alpha-0261-003