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RECRUITING
NCT07717905
PHASE1/PHASE2

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)

Sponsor: Bambusa Therapeutics

View on ClinicalTrials.gov

Summary

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-06-29

Completion Date

2028-06-30

Last Updated

2026-07-22

Healthy Volunteers

Yes

Interventions

DRUG

BBT001

BBT001 will be administered

DRUG

Placebo

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