A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants

Phase 1RecruitingNCT07005713

BeOne Medicines58 enrolled

Overview

This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Spontaneous Urticaria

Interventions

TacabrutidegDRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Part A * Participants must be diagnosed with chronic spontaneous urticaria (CSU) for ≥ 6 months before randomization. * The presence of itch and hives for ≥6 consecutive weeks at any time prior to randomization despite the use of second-generation H1-antihistamines * UAS7≥16 and HSS7≥8 during the 7 days before randomization * Participants must not have had any missing UAS7 entry (ISS7 and HSS7) during the 7 days before randomization * Presence of hives must have been documented within 3 months before randomization Part B * Participants must be 18 to 55 years of age and healthy, with no clinically relevant abnormalities. * Body Mass Index (BMI) of 18 to 32 kg/m\^2; and a total body weight \> 50 kg (110 lbs). Exclusion Criteria: Part A * Participants who have a clearly defined, predominating or sole trigger for their chronic urticaria (chronic inducible urticaria), including urticaria factitia (symptomatic dermographism) or cold, heat, solar, pressure, delayed pressure, aquagenic, cholinergic, or contact urticaria. * Other diseases with symptoms of urticaria or angioedema * Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. All Participants * Any uncontrolled disease state, including asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids. * Significant bleeding risk or coagulopathy. * Prior exposure to any BTK inhibitors or protein degraders. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (9)

Peking University Third Hospital

Beijing, Beijing Municipality, China

COMPLETED

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

COMPLETED

Outcomes

Primary Outcomes

Part A: Number of participants with adverse events (AEs)

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.

Time frame: Up to approximately 4 months

Part B: Number of participants with adverse events (AEs)

Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.

Time frame: Up to approximately 6 weeks

Part A: Maximum observed plasma concentration (Cmax) of tacabrutideg