This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
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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tracy.ji@bambusatx.com+86 18001322760
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.
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.
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.
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
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.
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.
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.
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.
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Guangzhou, Guangdong 510260, China
Guangzhou, Guangdong 510440, China
Jinzhou, Hubei 434020, China
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Xi’an, Shanxi 710114, China
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gyeyyx@163.com020-34153066
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