First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants

• ClinicalTrials.gov Identifier: NCT05093270
• Recruitment Status: Completed
• First Posted: October 26, 2021
• Last Update Posted: February 15, 2023
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: September 16, 2021
• First Posted Date: October 26, 2021
• Last Update Posted Date: February 15, 2023
• Actual Study Start Date: November 15, 2021
• Actual Primary Completion Date: September 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2021)

• Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 7 weeks ]
• Number of participants with clinically significant changes from baseline in vital signs [ Time Frame: 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 [ Time Frame: Up to approximately 4 weeks ]
  Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 21, 2021)

• Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D [ Time Frame: 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 [ Time Frame: Up to approximately 4 weeks ]
• Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D [ Time Frame: 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 [ Time Frame: Up to approximately 4 weeks ]
• Maximum observed plasma concentration (Cmax) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
• Time to maximum plasma concentration (Tmax) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
• Trough plasma concentration (Ctrough) for Parts A, B, and C [ Time Frame: Up to approximately 4 weeks ]
• Apparent terminal elimination half-life (t½) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
  in fed and fasted states for BGB-23339
• Apparent systemic clearance (CL/F) for Parts A, B, and C [ Time Frame: Up to approximately 4 weeks ]
• Apparent volume of distribution (Vz/F) for Parts A, B, and C [ Time Frame: 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 [ Time Frame: Up to approximately 4 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
• Official Title: A First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Subjects
• Brief Summary: This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Not Determined

Intervention

• Drug: BGB-23339
  Administered orally as a tablet
• Drug: Placebo
  Administered orally as a tablet

Study Arms

• Experimental: Part A Dose Escalation (Single Ascending Dose)
  Up to 5 dose levels of BGB-23339 or Placebo
  Interventions:

  • Drug: BGB-23339
  • Drug: Placebo
• Experimental: Part B Dose Escalation (Multiple Ascending Dose)
  Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A
  Interventions:

  • Drug: BGB-23339
  • Drug: Placebo
• Experimental: Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)
  Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)
  Interventions:

  • Drug: BGB-23339
  • Drug: Placebo
• Experimental: Part D (Food-Effect Study)
  Three single dose levels of BGB-23339 under different feeding conditions
  Intervention: Drug: BGB-23339

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2023): 92
• Original Estimated Enrollment (submitted: October 21, 2021): 115
• Actual Study Completion Date: December 26, 2022
• Actual Primary Completion Date: September 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Signed informed consent form (ICF) and able to comply with study requirements
2. 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
3. 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
4. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
5. 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

6. A woman of no childbearing potential must meet at least one of the following criteria:

   1. 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)
   2. Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).

Exclusion Criteria:

1. 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
2. Abnormal blood pressure as determined by the investigator
3. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
4. 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
5. 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
6. Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization
7. 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)
8. 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
9. Exposure to ≥ 4 new chemical entities within 12 months before randomization
10. Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization
11. Regular alcohol consumption ≤ 3 months before randomization
12. Regular use of recreational drugs
13. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, China

Administrative Information

• NCT Number: NCT05093270
• Other Study ID Numbers: BGB-23339-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: BeiGene
• Original Responsible Party: Same as current
• Current Study Sponsor: BeiGene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: BeiGene
• Verification Date: February 2023