BGB-23339 for Healthy Subjects

Overseen By BeiGene

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 11 weeks

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

For Part B only: Eligible Caucasian subjects should 1) have both biological parents and 4 biological grandparents of Caucasian descent, and 2) be matched by body weight (± 20% body weight [kg]), height (± 15% height [centimeter (cm)]) and sex to each Japanese subject receiving the highest dose level planned in Part A.

Subjects 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

Signed informed consent form (ICF) and able to comply with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of BGB-23339 or placebo to evaluate safety, tolerability, and pharmacokinetics

Up to 11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BGB-23339
• Placebo

How Is the Trial Designed?

Group I: Part B: Caucasian cohort Experimental Treatment 2 Interventions

One dose level of either BGB-23339 or placebo based on data collected in Part A.

Group II: Part A: Japanese cohort Experimental Treatment 2 Interventions

Three ascending dose levels of either BGB-23339 or placebo.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05387668

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-23339

BeiGene 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 ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-5-2022-c76ae

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, ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/beigene-trial-tyk2-inhibitor/

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- ...

5. synapse.patsnap.com synapse.patsnap.com/drug/5f8d8d161de447879c30f5ad5bb7c561

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.pdf

2. SYNOPSIS Across the single and multiple dose levels BGB-23339 demonstrated a favorable safety and tolerability profile in subjects during dose escalation. No subjects ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05093270?cond=BGB-23339&limit=10&rank=2

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.