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New pill aims to quiet chronic hives without the itch

NCT ID NCT07684560

Symptom relief Sponsor: AlphaMol Science Ltd. (Shanghai) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental tablet called Alpha-0261 in people with chronic spontaneous urticaria (long-lasting hives) and in healthy volunteers. The study checks the drug's safety, how the body processes it, and whether it reduces hive activity and itching. Participants take the tablet or a placebo daily for several weeks while continuing their usual antihistamine treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alpha-0261
What this could lead to
If successful, this could lead to a new oral treatment option for people with chronic hives that is easier to take than current therapies.
What could go wrong
This is an early Phase 1 trial with only 48 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic spontaneous urticaria (CSU) Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.