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
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 informed consent 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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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
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Bambusa Therapeutics