First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
- Registration Number
- NCT05093270
- Lead Sponsor
- BeiGene
- Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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Signed informed consent form (ICF) and able to comply with study requirements
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Healthy men and/or women of no childbearing potential of age ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent) for Parts A, B and D; of age≥ 18 years and ≤ 45 years on the day of signing the ICF (or the legal age of consent) and of Chinese descent for Part C
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Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
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Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
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A nonsterile man with a female partner of childbearing potential must be willing to use a highly effective method of birth control from the time of study enrollment until 90 days after the last dose of study drug
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A woman of no childbearing potential must meet at least one of the following criteria:
- Postmenopausal status, defined as: cessation of regular menses for ≥ 12 consecutive months (menopause confirmed by Follicular Stimulating Hormone [FSH] levels and Luteinizing Hormone [LH] levels as defined by the established reference ranges)
- Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data
- Abnormal blood pressure as determined by the investigator
- Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
- Any malignancies within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Past or intended use of prescription medication ≤ 14 days and over-the-counter (OTC) medication including herbal, vitamins and dietary supplements ≤ 7 days before randomization
- Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization
- Has received an investigational product within the following time before randomization: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer)
- Participation in a prior study that would result in loss of blood or blood products in excess of 500 mL within 56 days before randomization
- Exposure to ≥ 4 new chemical entities within 12 months before randomization
- Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization
- Regular alcohol consumption ≤ 3 months before randomization
- Regular use of recreational drugs
- Current use and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 14 days before randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Dose Escalation (Single Ascending Dose) BGB-23339 Up to 5 dose levels of BGB-23339 or Placebo Part D (Food-Effect Study) BGB-23339 Three single dose levels of BGB-23339 under different feeding conditions Part B Dose Escalation (Multiple Ascending Dose) Placebo Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A Part B Dose Escalation (Multiple Ascending Dose) BGB-23339 Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) BGB-23339 Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only) Part A Dose Escalation (Single Ascending Dose) Placebo Up to 5 dose levels of BGB-23339 or Placebo Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) Placebo Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events (AEs) Up to approximately 7 weeks Number of participants with clinically significant changes from baseline in vital signs Up to approximately 4 weeks Vital signs include blood pressure and pulse rate
Number of participants with clinically significant changes from baseline in clinical laboratory values Up to approximately 4 weeks Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D Up to approximately 4 weeks Apparent terminal elimination half-life (t½) for Parts A, B, C and D Up to approximately 4 weeks in fed and fasted states for BGB-23339
Time to maximum plasma concentration (Tmax) for Parts A, B, C and D Up to approximately 4 weeks Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D Up to approximately 4 weeks Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D Up to approximately 4 weeks Maximum observed plasma concentration (Cmax) for Parts A, B, C and D Up to approximately 4 weeks Trough plasma concentration (Ctrough) for Parts A, B, and C Up to approximately 4 weeks Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only Up to approximately 4 weeks Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D Up to approximately 4 weeks Apparent systemic clearance (CL/F) for Parts A, B, and C Up to approximately 4 weeks Apparent volume of distribution (Vz/F) for Parts A, B, and C Up to approximately 4 weeks
Trial Locations
- Locations (3)
Q PHARM
🇦🇺Herston, Queensland, Australia
Nucleus Network
🇦🇺Melbourne, Victoria, Australia
The Affiliated Hospital of Qingdao University Branch West Coast
🇨🇳Qingdao, Shandong, China