BGB-23339 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the new treatment, BGB-23339, affects healthy Japanese and Caucasian individuals, focusing on its safety and metabolism. Participants will receive either the treatment or a placebo, an inactive substance. The trial consists of two parts: Japanese participants will try different dose levels, while Caucasian participants will receive a single dose level. Individuals who are healthy and have all grandparents of either full Japanese or Caucasian descent may qualify. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants, it is likely that you should not be on any regular medications that could affect the study results.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that BGB-23339 is generally well-tolerated. In earlier studies, participants who took one or more doses of BGB-23339 experienced a good safety profile, meaning most handled the treatment well without major problems. No serious side effects occurred when the dose gradually increased. This suggests that BGB-23339 is generally safe. However, it's important to remember that this information comes from early trials, and more research is needed to confirm these findings.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about BGB-23339 because it offers a novel approach to treatment by targeting specific pathways that current medications do not. Unlike standard treatments, which may focus on broader mechanisms, BGB-23339 is designed to work with precision, potentially leading to fewer side effects and improved outcomes. This new drug is being tested in both Japanese and Caucasian populations, which could provide insights into how different genetic backgrounds respond to the treatment, making it a promising candidate for personalized medicine.
What evidence suggests that BGB-23339 could be effective?
Research has shown that BGB-23339 is a promising treatment because it targets TYK2, a part of the immune system linked to inflammation. Early studies demonstrated that BGB-23339 successfully blocked proteins such as IL-12 and IL-23, which contribute to inflammation. This suggests potential benefits for conditions related to inflammation. In this trial, participants will receive either BGB-23339 or a placebo. Although BGB-23339 has only been tested on animals and healthy volunteers so far, its targeted action offers hope for future treatments.13467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple doses of BGB-23339 or placebo to evaluate safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BGB-23339
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
One dose level of either BGB-23339 or placebo based on data collected in Part A.
Three ascending dose levels of either BGB-23339 or placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor
Citations
Safety, Tolerability, and Pharmacokinetics of BGB-23339 in ...
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome ...
2.
businesswire.com
businesswire.com/news/home/20211122005809/en/BeiGene-Initiates-First-in-Human-Phase-1-Clinical-Trial-of-Investigational-TYK2-Inhibitor-BGB-23339BeiGene Initiates First-in-Human Phase 1 Clinical Trial of ...
BGB-23339 is a potent, highly selective, investigational TYK2 inhibitor targeting the regulatory pseudokinase (JH2) domain. “Discovered and ...
Safety, Tolerability, and Pharmacokinetics of BGB-23339 in ...
This trial tests a new drug called BGB-23339 in healthy Japanese and Caucasian people. It aims to find out if there are any differences in safety, ...
BeiGene commences Phase I trial of TYK2 inhibitor BGB- ...
In preclinical trials, BGB-23339 showed robust selectivity to hinder interleukin (IL)-12, IL-23, and Type 1 interferons (IFNs). These pro- ...
BGB-23339 - Drug Targets, Indications, Patents
“Discovered and developed by BeiGene, BGB-23339 is a highly selective, potent, allosteric TYK2 inhibitor that has shown promising activity in preclinical ...
6.
beonemedicines.com
beonemedicines.com/wp-content/uploads/2025/10/BGB-233391-101-CSR-Synopsis-2023SEP02_Redacted.pdf2. SYNOPSIS
Across the single and multiple dose levels BGB-23339 demonstrated a favorable safety and tolerability profile in subjects during dose escalation. No subjects ...
Study Details | NCT05093270 | First-in-Human, Single- and ...
... Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Subjects ... Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A.
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