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.
1 other identifier
interventional
48
1 country
10
Brief Summary
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2026
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2026
CompletedFirst Submitted
Initial submission to the registry
July 16, 2026
CompletedFirst Posted
Study publicly available on registry
July 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
July 22, 2026
July 1, 2026
1.5 years
July 16, 2026
July 21, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Number of participants with adverse events following multiple administration of BBT001
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v6.0.
- Up to Day 183 post first dose administration
Number of participants with change in vital sign measurements following treatment administration.
Blood pressure and heart rate will be assessed.
Up to Day 183 post first dose administratio
Number of participants with change in serum blood parameters.
Laboratory assessments include hematology, blood chemistry and coagulation test
Up to Day 183 post first dose administration
Number of participants with change in physical examination following treatment administration
Physical examination will be assessed
Up to Day 183 post first dose administration
Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration.
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
Up to Day 183 post first dose administration
Secondary Outcomes (7)
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
At specified timepoints pre-dose and up to 183 days post first dose administration]
Pharmacokinetics parameters- Area under the curve (AUC)
At specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- Volume of distribution (Vz)
At specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
specified timepoints pre-dose and up to 183 days post first dose administration
Pharmacokinetics parameters- Total clearance (CL)
At specified timepoints pre-dose and up to 183 days post first dose administration
- +2 more secondary outcomes
Study Arms (8)
Cohort A1:BBT001 (450mg biologic naive)
ACTIVE COMPARATORA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.
Cohort A1:Placebo (450mg biologic naive)
PLACEBO COMPARATORA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU)who are naïve to biologic therapy.
Cohort A2:BBT001 (450mg biologic experienced)
ACTIVE COMPARATORA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.
Cohort A1:placebo (450mg biologic experienced)
PLACEBO COMPARATORA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy
Cohort A3:BBT001 (900mg biologic naive)
ACTIVE COMPARATORA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.
Cohort A3:Placebo (900mg biologic naive)
PLACEBO COMPARATORA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.
Cohort A4:BBT001 (900mg biologic experienced)
ACTIVE COMPARATORA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.
Cohort A4:Placobo (900mg biologic experienced)
PLACEBO COMPARATORA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.
Interventions
BBT001 will be administered
Placebo will be administered
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Peking University People's Hospital, Beijing
Beijing, Beijing Municipality, 100032, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510440, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Jingzhou Central Hospital
Jinzhou, Hubei, 434020, China
Wuxi Second People's Hospital,
Wuxi, Jiangsu, 214002, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710114, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2026
First Posted
July 21, 2026
Study Start
June 29, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share