Chronic Spontaneous Urticaria (CSU)Phase 1NCT07684560
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 1 study testing Alpha-0261 in people with Chronic Spontaneous Urticaria (CSU) and Healthy Volunteers, run by AlphaMol Science Ltd. (Shanghai) at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
- What is being tested?
- Alpha-0261
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianzhong Zhang, M.D., +8601088325471, rmzjz@126.com
About this study
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.
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.
- Being tested
- Alpha-0261, Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-0261Drug
Oral, tablet
PlaceboOther
Oral, tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Alpha-0261 |
| Placebo (Part 1) | Placebo comparator | Matched placebo control of cohort 1 to 4. Receives: Other: Placebo |
| Single Dose (Part 2) | Experimental | Single Dose of Alpha-0261. Alpha-0261 is administered once per treatment cycle. Two treatment cycles. Receives: Drug: Alpha-0261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From enrollment to the end of treatment at 4 weeks.
Pharmacokinetics Cmax (Part 2)
Cmax: Maximum Plasma Concentration
Measured: From enrollment to end of follow-up visit, up to approximately 1 week.
Pharmacokinetics AUC (part 2)
AUC: Area Under the Concentration-time Curve
Measured: From enrollment to end of follow-up visit, up to approximately 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlphaMol Science Ltd. (Shanghai)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684560
- Sponsor's protocol ID
- Alpha-0261-003
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07684560
- Acronym / sponsor ID
- Alpha-0261-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AlphaMol Science Ltd. (Shanghai)Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple Ascending Dose (Part 1) | Experimental | Drug: Alpha-026150 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. |
| Placebo (Part 1) | Placebo comparator | Other: PlaceboMatched placebo control of cohort 1 to 4. |
| Single Dose (Part 2) | Experimental | Drug: Alpha-0261Single Dose of Alpha-0261. Alpha-0261 is administered once per treatment cycle. Two treatment cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-0261Oral, tablet | Drug | Multiple Ascending Dose (Part 1), Single Dose (Part 2) |
| PlaceboOral, tablet | Other | Placebo (Part 1) |
Primary outcome
Frequency of treatment emergent adverse events
Time frame: 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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpha-0261 in people with Chronic Spontaneous Urticaria (CSU) and Healthy Volunteers, run by AlphaMol Science Ltd. (Shanghai) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huang Yu, PhD (+8618914791983, yu.huang@alphamol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment emergent adverse events (time frame: Part 1: approximately 6 weeks Part 2: approximately 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.