Recruiting

Safety and Efficacy of BBT001 in Adults with Chronic Spontaneous Urticaria

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Study Aim

This study aims to evaluate the safety and effectiveness of BBT001 in adults with Chronic Spontaneous Urticaria, by observing adverse events, changes in vital signs, blood parameters, physical examinations, and electrocardiogram results following treatment administration.

What is being tested

BBT001

+ Placebo

+ BBT001

Drug
Who is being recruted

Chronic Disease+9

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 18 to 75 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: June 2026
See protocol details

Summary

Principal SponsorBambusa Therapeutics
Study ContactTracy Ji, Study DirectorMore contacts
Last updated: July 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 29, 2026

Actual date on which the first participant was enrolled.

The study consists of below cohorts: Cohort A1 (biologic-naïve): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A2 (biologic-experienced): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A3 (biologic-naïve) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4) Cohort A4 (biologic-experienced) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4)

NCT07717905
Principal SponsorBambusa Therapeutics
Study ContactTracy Ji, Study DirectorMore contacts
Last updated: July 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, VascularDisease AttributesChronic Urticaria

Criteria

1 exclusion criteria prevent from participating
-

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

8 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.

Group II

Placebo
A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU)who are naïve to biologic therapy.

Group III

Active Comparator
A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.

Group IV

Placebo
A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy

Group 5

Active Comparator
A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.

Group 6

Placebo
A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.

Group 7

Active Comparator
A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.

Group 8

Placebo
A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Recruiting

Peking University People's Hospital, Beijing

Beijing, ChinaOpen Peking University People's Hospital, Beijing in Google Maps
Recruiting soon

The Second Affiliated Hospital of Wannan Medical College

Wuhu, China
Recruiting soon

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China
Recruiting soon

Dermatology Hospital of Southern Medical University

Guangzhou, China
Recruiting
10 Study Centers