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Bruton's Tyrosine Kinase (BTK) Inhibitor

Zanubrutinib for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing zanubrutinib in tablet and capsule forms to see how well each is absorbed and how food affects the tablet form. It is likely aimed at patients with certain blood cancers, and the medication works by stopping cancer cells from growing. Zanubrutinib is a medication approved for treating adults with a type of blood cancer who have already tried other treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of participants with clinically significant laboratory values
Number of participants with clinically significant vital sign measurements

Side effects data

From 2024 Phase 3 trial • 652 Patients • NCT03734016
24%
Diarrhoea
20%
Hypertension
18%
Neutropenia
16%
COVID-19
16%
Arthralgia
15%
Anaemia
14%
Upper respiratory tract infection
13%
Muscle spasms
13%
Fatigue
12%
Rash
11%
Atrial fibrillation
10%
Thrombocytopenia
10%
Nausea
10%
Pyrexia
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Pain in extremity
7%
Epistaxis
7%
Peripheral swelling
7%
Constipation
7%
Oedema peripheral
7%
Back pain
7%
Dizziness
6%
Dyspepsia
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Hyperuricaemia
6%
Decreased appetite
6%
Bronchitis
5%
Petechiae
5%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
4%
Palpitations
4%
Blood pressure increased
4%
Dyspnoea
4%
Gastrooesophageal reflux disease
4%
COVID-19 pneumonia
4%
Cellulitis
4%
Haematuria
4%
Sinusitis
4%
Alanine aminotransferase increased
4%
Weight decreased
4%
Haematoma
4%
Oral herpes
4%
Myalgia
4%
Squamous cell carcinoma of skin
3%
Basal cell carcinoma
3%
Anxiety
3%
Nasopharyngitis
3%
Gout
3%
Oropharyngeal pain
3%
Paronychia
3%
Skin infection
3%
Paraesthesia
3%
Conjunctivitis
3%
Mouth ulceration
3%
Asthenia
3%
Pharyngitis
3%
Aspartate aminotransferase increased
3%
Productive cough
2%
Vertigo
2%
Pruritus
2%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Pleural effusion
1%
Mastoiditis
1%
Transient ischaemic attack
1%
Abdominal pain upper
1%
Death
1%
Adenocarcinoma gastric
1%
Lung adenocarcinoma
1%
Cerebral infarction
1%
Syncope
1%
Cardiac arrest
1%
Respiratory failure
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
1%
Pneumocystis jirovecii pneumonia
1%
Septic shock
1%
Haemolytic anaemia
1%
Subdural haematoma
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Myocardial infarction
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrutinib
Zanubrutinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Dose CohortExperimental Treatment1 Intervention
Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences
Group II: High Dose CohortExperimental Treatment1 Intervention
Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~2160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BeiGeneLead Sponsor
197 Previous Clinical Trials
30,693 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,276 Previous Clinical Trials
499,234 Total Patients Enrolled
~13 spots leftby Nov 2025