NCT06979518CompletedPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 13 May 2025
- Start date
- 20 May 2025
- Primary completion date
- 22 Apr 2026
- Lead sponsor
- GlaxoSmithKline
- Diseases
- COPD
- NCT number
- NCT06979518
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 20 May 2025 to the primary completion date, 22 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug
- Symptomatic herpes zoster within 3 months prior to screening
- 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)
- Positive hepatitis Bor hepatitis C test at screening or within 3 months prior to study intervention.
- Positive prestudy drug/alcohol test
- 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
Other illness
- 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
- 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 positive confirmation of SARS-CoV-2 infection at pre-dose
- Evidence of active or latent Tuberculosis (TB)
- 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)
Other
- Abnormal blood pressure (as determined by the investigator)
- A clinically significant abnormality in the average of triplicate 12-lead ECG readings performed at screening including
- Current enrolment or past participation in this clinical study
- An average weekly intake of \>14 units of alcohol
- The participant has a phobia to needles
Who the study is looking for
- 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•
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.