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.
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
Locations
Other Locations
China
Peking University People's Hospital, Beijing
RECRUITING
Beijing
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Hangzhou Third People's Hospital
NOT_YET_RECRUITING
Hangzhou
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jinzhou
The First Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The Second Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
Wuxi Second People's Hospital,
NOT_YET_RECRUITING
Wuxi
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
Contact Information
Primary
Tracy Ji, Study Director
tracy.ji@bambusatx.com
+86 18001322760
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 48
Treatments
Active_comparator: Cohort A1:BBT001 (450mg biologic naive)
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.
Placebo_comparator: Cohort A1:Placebo (450mg biologic naive)
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.
Active_comparator: Cohort A2:BBT001 (450mg biologic experienced)
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.
Placebo_comparator: Cohort A1:placebo (450mg biologic experienced)
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
Active_comparator: Cohort A3:BBT001 (900mg biologic naive)
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.
Placebo_comparator: Cohort A3:Placebo (900mg biologic naive)
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.
Active_comparator: Cohort A4:BBT001 (900mg biologic experienced)
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.
Placebo_comparator: Cohort A4:Placobo (900mg biologic experienced)
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.
Related Therapeutic Areas
Sponsors
Leads: Bambusa Therapeutics