CompletedPhase 1

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

Australia, China92 participantsStarted 2021-11-15

Plain-language summary

This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to approximately 7 weeks

Number of participants with clinically significant changes from baseline in vital signs

Timeframe: Up to approximately 4 weeks

Number of participants with clinically significant changes from baseline in clinical laboratory values

Timeframe: Up to approximately 4 weeks

NCT IDNCT05093270

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-15

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to approximately 7 weeks

Number of participants with clinically significant changes from baseline in vital signs

Timeframe: Up to approximately 4 weeks

Number of participants with clinically significant changes from baseline in clinical laboratory values

Timeframe: Up to approximately 4 weeks