BGB-45035
DrugAdministered orally
NCT Number: NCT06342713
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F.
Study details include:
* The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Innovate Clinical Research, Waitara, New South Wales, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Parts A-D and Part F:
Inclusion criteria
for Part E
General Inclusion Criteria:
Exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered orally
Administered orally
Time frame: From the first dose of study drug to 30 days after the last dose; up to approximately 44 days for Parts A-D and up to 16 weeks for Part E
Time frame: Baseline and up to approximately 1 month
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Time frame: Baseline and up to approximately 1 month
Vital signs include blood pressure and pulse rate
Time frame: Baseline and up to approximately 1 month
As assessed via 12-lead electrocardiogram (ECG)
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Up to approximately 14 days
Time frame: Baseline and up to 16 weeks
Time frame: Baseline and up to 16 weeks
Time frame: Baseline and up to 16 weeks
Time frame: Baseline and up to 16 weeks
Time frame: Baseline and up to 16 weeks
Time frame: Baseline and up to 16 weeks
BeiGene
Industry
Phase 1a/1b Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and Its Safety and Tolerability in Patients With Autoimmune Dermatological Diseases
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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