Clinical trial NCT06979518: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK3862995B Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and European Ancestry
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK3862995B Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and European Ancestry
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GSK3862995B
Chinese
Japanese
and European ancestry
Healthy Participants
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, placebo-controlled, double-blind study
Primary purpose: TREATMENT

Brief summary: This study aims to assess the ethnic sensitivity of GSK3862995B in terms of safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) in healthy participants of Chinese, Japanese, and European ancestry to enable the inclusion of Chinese and Japanese participants in future global studies.


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 to 50 years of age inclusive
* Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, laboratory tests, and cardiac monitoring
* Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
* Body mass index (BMI) within the range of 18.0 to 28.0 kilogram per square meter (kg/m\^2) (inclusive)
* Capable of giving signed informed consent
* Males and females of non-childbearing potential•

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
* A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug
* Abnormal blood pressure (as determined by the investigator)
* Symptomatic herpes zoster within 3 months prior to screening
* Significant allergies to humanized monoclonal antibodies
* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
* Lymphoma, leukemia, or any malignancy 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
* Breast cancer within the past 10 years
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* A clinically significant abnormality in the average of triplicate 12-lead ECG readings performed at screening including
* Antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal therapy within 30 days of dosing
* Past or intended use of over the counter or prescription medication (including herbal medications) within 7 days prior to dosing and for the duration of study participation
* Live vaccine(s) within 30 days prior to screening or plans to receive such vaccines during the study
* Treatment with biologic agents within 12 weeks, 5 half-lives or twice the duration of the biological effect of the biologic agent (whichever is longer) prior to dosing
* Participation in other clinical study that resulted in loss of blood or blood products \>500 millilitres (mL) within a 56 days before participation in this study
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
* Current enrolment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered prior to the first dosing day: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer)
* Current enrolment or past participation in this clinical study
* A positive confirmation of SARS-CoV-2 infection at pre-dose
* Evidence of active or latent Tuberculosis (TB)
* Positive hepatitis Bor hepatitis C test at screening or within 3 months prior to study intervention.
* Positive prestudy drug/alcohol test
* An average weekly intake of \>14 units of alcohol
* Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC)
* Current smoker or user or tobacco- or nictotine- containing products, within 30 days prior to screening visit
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
* Any products intended to treat medical conditions that are not approved by the governing health authority (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc)
* The participant has a phobia to needles

Primary outcomes:
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to Week 44 (End of follow up visit)
measure: Number of Participants with Serious Adverse Events (SAE)
timeFrame: Up to Week 44 (End of follow up visit)
measure: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
timeFrame: Up to Week 36
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Week 36
measure: Number of Participants with Clinically Significant Changes in 12-lead (Electrocardiogram (ECG)
timeFrame: Up to Week 36
measure: Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3862995B
timeFrame: Up to Week 36
measure: Maximum Observed Concentration (Cmax) of GSK3862995B
timeFrame: Up to Week 36
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: