A Phase 1/2 interventional study of BBT001 and Placebo in Chronic Spontaneous Urticaria, sponsored by Bambusa Therapeutics. Recruiting at 10 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Bambusa Therapeutics · Phase 1/2, Interventional, and Treatment
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Among 34 studies in Chronic Urticaria with a site in China — 16 open to participants now, 20 under way, 5 of them phase 3. Chronic Urticaria · China.
Among the 34 studies in Chronic Urticaria with a site in China, this one is the 22nd largest by planned enrollment of the 30 interventional ones that give a count, is one of 11 that started in 2026, is one of 4 in phase 1/2, reaches primary completion later than 17 of the 19 other live ones, and was the 32nd registered.
196 studies on the registry are indexed under Chronic Urticaria; 48 are open to participants now.
Browse Chronic Urticaria studies →16 of the 34 studies in Chronic Urticaria with a site in China are open now. Recruiting first, the newest first:
Novelty Nobility, Inc. · Sites in China
Ages 18–75 · Healthy volunteers
Yuhan Corporation · Sites in China, Bulgaria, Poland and 1 more country
Ages 18–75
Jemincare · Sites in China
Ages 18+
Beijing InnoCare Pharma Tech Co., Ltd. · Sites in China
Ages 18–75
Keymed Biosciences Co.Ltd · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 25 Chronic Urticaria studies recruiting now, 11 (44%) set no upper age limit and 10 (40%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 13 · Phase 3 10
First in 2013; this study’s year is marked. 11 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 80 across 147 interventional studies indexed under Chronic Urticaria.
Median enrollment 110 across the 30 interventional studies, 270 across the 4 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 34 have an industry lead sponsor. The 10 most frequent:
Bambusa Therapeutics is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Bambusa Therapeutics has 1 study filed under Chronic Urticaria — fewer than ten, so there is no comparison to draw.
10 of the studies in Chronic Urticaria with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07402213Phase 3JemincareTrial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria. | 2027-06-07 |
| NCT06604949Longbio PharmaA Study of Single Dose of LP-003 in Healthy Adult Subjects | 2026-11 |
| NCT07005713BeOne MedicinesA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants | 2026-11-30 |
| NCT07613866Chengdu Suncadia Medicine Co., Ltd.A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria | 2026-12 |
| NCT07219615PfizerA Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. | 2026-12-25 |
Add all 10 to your calendar (.ics) → With an account.
Among the 34 studies in Chronic Urticaria with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
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)
Inclusion Criteria: key inclusion criteria: 1)Male or female 18 to 75 years (inclusive) of age at time of consent. 2)Capped weight to be no more than 125 kg at screening.3)UAS7>=16; 4)Patients must have been on daily stable doses of H1-AH;5) Written obtained from the participant prior to performing any protocol-related procedures. For A2/A4 only: Participants who have received prior treatment with any biological products (e.g., omalizumab or dupilumab) . The last dose≥ 5 half-lives prior to randomization.
Exclusion Criteria: key exclusion criteria: 1）Inducible urticaria ; 2） Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis ；3） Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes; 4)History of herpes simplex infection; 5 ）Serological abnormalities of infection at screening .
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: BBT001
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.
Drug: 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.
Drug: BBT001
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
Drug: 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.
Drug: BBT001
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.
Drug: 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.
Drug: BBT001
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.
Drug: Placebo
BBT001 will be administered
Placebo will be administered
Number of participants with adverse events following multiple administration of BBT001
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v6.0.
Time frame: - Up to Day 183 post first dose administration
Number of participants with change in vital sign measurements following treatment administration.
Blood pressure and heart rate will be assessed.
Time frame: Up to Day 183 post first dose administratio
Number of participants with change in serum blood parameters.
Laboratory assessments include hematology, blood chemistry and coagulation test
Time frame: Up to Day 183 post first dose administration
Number of participants with change in physical examination following treatment administration
Physical examination will be assessed
Time frame: Up to Day 183 post first dose administration
Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration.
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
Time frame: Up to Day 183 post first dose administration
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
Serum PK Tmax will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]
Pharmacokinetics parameters- Area under the curve (AUC)
Area under the curve of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- Volume of distribution (Vz)
Volume of distribution of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Time frame: specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- Total clearance (CL)
Total clearance of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- - Elimination Half-life (t1/2).
Elimination half-life of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
Serum Anti-Drug Antibodies will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: BBT001
Bambusa Therapeutics