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

NCT07005713 · tracked via the Priya Life Science China tracker

Sponsor

BeOne Medicines

Phase

Phase 1

Started

2025-07-19

Last updated

2026-09-09

Condition(s) studied

Chronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

TacabrutidegPlacebo

Tacabrutideg: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Part A: Number of participants with adverse events (AEs) — Up to approximately 4 months
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.
Part B: Number of participants with adverse events (AEs) — Up to approximately 6 weeks
Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.
Part A: Maximum observed plasma concentration (Cmax) of tacabrutideg — Up to approximately 10 weeks
Part A: Minimum observed plasma concentration (Cmin) of tacabrutideg — Up to approximately 10 weeks
Part A: Time to reach maximum observed plasma concentration (Tmax) of tacabrutideg — Up to approximately 10 weeks
Part A: Apparent terminal elimination half life (t1/2) of tacabrutideg — Up to approximately 10 weeks
Part A: Area under the curve (AUC) of tacabrutideg — Up to approximately 10 weeks
Part A: Apparent oral clearance (CL/F) of tacabrutideg — Up to approximately 10 weeks
Part A: Apparent volume of distribution (Vz/F) of tacabrutideg — Up to approximately 10 weeks
Part A: Accumulation Ratio of AUC for tacabrutideg — Up to approximately 10 weeks
Part A: Accumulation Ratio of Cmax for tacabrutideg — Up to approximately 10 weeks

Trial sites (9)

Facility	City	Region	Status
Peking University Third Hospital	Beijing	Beijing Municipality	Completed
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Completed
Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong	Completed
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Completed
Xiangya Hospital of Central South University	Changsha	Hunan	Completed
The Affiliated Hospital of Qingdao University Branch West Coast	Qingdao	Shandong	Recruiting
Chengdu Second Peoples Hospital	Chengdu	Sichuan	Completed
Hangzhou First Peoples Hospital	Hangzhou	Zhejiang	Completed
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	Completed

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Other trials for the same condition

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib Active, not recruiting

A Study of Efficacy and Safety of TLL-018 in CSU Participants Active, not recruiting

A Study of Single Dose of LP-003 in Healthy Adult Subjects Active, not recruiting

24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up Active, not recruiting

To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07005713 on ClinicalTrials.gov ↗ ← All trials in China