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).

NCT07684560 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Alpha-0261-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria (CSU); Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1)

  From enrollment to the end of treatment at 4 weeks.

• Pharmacokinetics Cmax (Part 2)

  From enrollment to end of follow-up visit, up to approximately 1 week.

• Pharmacokinetics AUC (part 2)

  From enrollment to end of follow-up visit, up to approximately 1 week.

Study Arms (3)

Multiple Ascending Dose (Part 1)

EXPERIMENTAL

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

Placebo (Part 1)

PLACEBO COMPARATOR

Matched placebo control of cohort 1 to 4.

Other: Placebo

Single Dose (Part 2)

EXPERIMENTAL

Single Dose of Alpha-0261. Alpha-0261 is administered once per treatment cycle. Two treatment cycles.

Drug: Alpha-0261

Interventions

Alpha-0261 DRUG

Oral, tablet

Multiple Ascending Dose (Part 1); Single Dose (Part 2)

Placebo OTHER

Oral, tablet

Placebo (Part 1)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• AlphaMol Science Ltd. (Shanghai): lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Huang Yu, PhD

CONTACT

+8618914791983; yu.huang@alphamol.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)