RecruitingPhase 1Phase 2NCT07717905

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)

A Randomized, Double-Blind, Placebo-controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Adult Patients With Chronic Spontaneous Urticaria.

Sponsor

Bambusa Therapeutics

Enrollment

48 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Spontaneous Urticaria

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BBT001 and a drug called Placebo for people with chronic spontaneous urticaria. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBBT001

BBT001 will be administered

DRUGPlacebo

Placebo will be administered

Locations(10)

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Peking University People's Hospital, Beijing

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Jingzhou Central Hospital

Jinzhou, Hubei, China

Wuxi Second People's Hospital,

Wuxi, Jiangsu, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07717905

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