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).

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers; Chronic Spontaneous Urticaria (CSU)
• Intervention / Treatment: Other: Placebo; Drug: Alpha-0261

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huang Yu, PhD; Phone Number: +8618914791983; Email: yu.huang@alphamol.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital
      • Contact: Jianzhong Zhang, M.D.; Phone Number: +8601088325471; Email: rmzjz@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Ascending Dose (Part 1); 50 mg (25 mg tablet), 125 mg (125 mg tablet), 250 mg (125 mg tablet), and 500 mg (125 mg tablet) of Alpha-0261 will be administered QD for 4 weeks, orally to subjects in the treatment group, cohort 1 to 4.	Drug: Alpha-0261; Oral, tablet
Placebo Comparator: Placebo (Part 1); Matched placebo control of cohort 1 to 4.	Other: Placebo; Oral, tablet
Experimental: Single Dose (Part 2); Single Dose of Alpha-0261. Alpha-0261 is administered once per treatment cycle. Two treatment cycles.	Drug: Alpha-0261; Oral, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Part 1: approximately 6 weeks Part 2: approximately 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 4 weeks.
Pharmacokinetics Cmax (Part 2)	Cmax: Maximum Plasma Concentration	From enrollment to end of follow-up visit, up to approximately 1 week.
Pharmacokinetics AUC (part 2)	AUC: Area Under the Concentration-time Curve	From enrollment to end of follow-up visit, up to approximately 1 week.

Collaborators and Investigators

• Sponsor: AlphaMol Science Ltd. (Shanghai)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: Alpha-0261-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No