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

NCT06979518 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 223982
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

GSK3862995B; Chinese; Japanese; and European ancestry; Healthy Participants; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Immunogenicity

Outcome Measures

Primary Outcomes (7)

• Number of Participants with Adverse Events (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

  Up to Week 44 (End of follow up visit)

• Number of Participants with Serious Adverse Events (SAE)

  An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or abnormal pregnancy outcomes (such as, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy).

  Up to Week 44 (End of follow up visit)

• Number of Participants with Clinically Significant Changes in Clinical Laboratory Values

  Number of Participants with clinically significant changes in clinical laboratory values (hematology, chemistry and urinalysis) will be assessed.

  Up to Week 36

• Number of Participants with Clinically Significant Changes in Vital Signs

  Number of Participants with clinically significant changes in vital signs will be assessed.

  Up to Week 36

• Number of Participants with Clinically Significant Changes in 12-lead (Electrocardiogram (ECG)

  Number of Participants with clinically significant changes in 12-lead ECG will be assessed.

  Up to Week 36

• Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3862995B

  Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.

  Up to Week 36

• Maximum Observed Concentration (Cmax) of GSK3862995B

  Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.

  Up to Week 36

Study Arms (2)

GSK3862995B

EXPERIMENTAL

Participants of Chinese, Japanese, or European ancestries will receive GSK3862995B.

Drug: GSK3862995B

Placebo

EXPERIMENTAL

Participants of Chinese, Japanese, or European ancestries will receive matching placebo.

Drug: Placebo

Interventions

GSK3862995B DRUG

GSK3862995B will be administered.

GSK3862995B

Placebo DRUG

Matching placebo will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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•

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blind study where participants Care provider (site staff) and investigator will remain blinded throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, placebo-controlled, double-blind study

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: May 20, 2025
• Primary Completion: November 25, 2025
• Study Completion: April 27, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.