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)
Recruiting
Phase 1
Phase 2
Interventional Study
Chronic Spontaneous Urticaria
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Bambusa Therapeutics · Industry
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About This Trial
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
Trial Locations
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Eligibility Criteria
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 pr…
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