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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU)

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllBambusa Therapeutics
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In plain words

What the trial is, and whether it could suit you

This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • BBT001
  • Placebo
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Where

10 sites
The Second Affiliated Hospital of Wannan Medical College
Wuhu, China
Peking University People's Hospital, Beijing
Beijing, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
Jingzhou Central Hospital
Jinzhou, China
Wuxi Second People's Hospital,
Wuxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, China

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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