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)

Phase 2RecruitingNCT07717905

Bambusa Therapeutics48 enrolled

Overview

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

The study consists of below cohorts: Cohort A1 (biologic-naïve): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A2 (biologic-experienced): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A3 (biologic-naïve) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4) Cohort A4 (biologic-experienced) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Spontaneous Urticaria

Interventions

BBT001DRUG

BBT001 will be administered

PlaceboDRUG

Placebo will be administered

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 prior to performing any protocol-related procedures. For A2/A4 only: Participants who have received prior treatment with any biological products (e.g., omalizumab or dupilumab) . The last dose≥ 5 half-lives prior to randomization. Exclusion Criteria: key exclusion criteria: 1）Inducible urticaria ; 2） Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis ；3） Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes; 4)History of herpes simplex infection; 5 ）Serological abnormalities of infection at screening . \-

Locations (10)

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

NOT_YET_RECRUITING

Peking University People's Hospital, Beijing

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Number of participants with adverse events following multiple administration of BBT001

Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v6.0.

Time frame: - 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.

Time frame: 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

Time frame: Up to Day 183 post first dose administration

Number of participants with change in physical examination following treatment administration

Physical examination will be assessed

Time frame: 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.

Time frame: Up to Day 183 post first dose administration

Secondary Outcomes

Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)

Serum PK Tmax will be analyzed for all subjects

Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]

Pharmacokinetics parameters- Area under the curve (AUC)

Central Contacts

Tracy Ji, Study Director

CONTACT

+86 18001322760 tracy.ji@bambusatx.com

Data from ClinicalTrials.gov

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