A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- a… (NCT06342713) | Clinical Trial Compass
CompletedPhase 1
A 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 in Adults With Autoimmune Dermatological Diseases
Australia, China, New Zealand203 participantsStarted 2024-06-20
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female or male participants between the ages of 18 and 55 years inclusive (ages 18 and 45 years for Part C).
. BMI of 18 to 32 kg/m\^2; and a total body weight \> 50 kg (110 lbs).
. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
. Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 90 days after the last dose of study drug.
. Female participants of childbearing potential can only join Part F and must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 90 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since BGB-45035 is only in Phase 1 and this study was primarily designed to test safety and tolerability rather than whether it actually treats atopic dermatitis or prurigo nodularis, what do the early safety results tell us about whether it's reasonable to consider this drug further — and are there already established treatments I should try first?
2This trial specifically monitored participants for changes in cardiac conduction intervals, which can signal heart rhythm concerns — has my doctor seen any signals from this study's results that would make them cautious about this drug for someone with my health profile?
3The trial is now completed, so the data should exist — has my doctor been able to review any published or shared findings on adverse events from Parts A through E, and what do those results suggest about how well the drug was tolerated?
4Since this was a study in both healthy volunteers and people with autoimmune skin diseases, does my doctor think the safety profile observed in healthy participants is a reliable indicator of how someone with my condition might respond to BGB-45035?
5Given that this Phase 1 trial has finished but likely hasn't yet led to a larger Phase 2 or 3 study proving effectiveness, what would my doctor recommend as the best treatment path for my condition right now while research on drugs like this continues?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Adverse Events (AEs) in Parts A-E
Timeframe: 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
2
Parts A-D: Number of participants with clinically significant changes from baseline in clinical laboratory values
Timeframe: Baseline and up to approximately 1 month
3
Parts A-D: Number of participants with clinically significant changes from baseline in vital signs
Timeframe: Baseline and up to approximately 1 month
4
Parts A-D: Number of participants with clinically significant changes from baseline in cardiac conduction intervals
Timeframe: Baseline and up to approximately 1 month
. Female or male participants between the ages of 18 to 75 years of age.
. Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 90 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.
Exclusion criteria
. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
. Any condition possibly affecting drug absorption (eg, gastrectomy or cholecystectomy).
. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer.
. Clinically significant abnormality on chest radiograph performed at screening or within 3 months of screening date.
. History of tuberculosis or active or latent or inadequately treated infection, positive IGRA tests
. Herbal supplements (including St. John's Wort) and hormone replacement therapy must be discontinued 14 days prior to the first dose of study medication.
. Vaccination with live virus, attenuated live virus, or any live viral components within the 6 weeks prior to the first dose of study drug or is to receive these vaccines at any time during treatment or within 8 weeks following completion of study treatment.