Pulmonary Disease, Chronic ObstructivePhase 1NCT06979518
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 study testing GSK3862995B in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK3862995B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2025to 22 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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•
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Cypress, California, 90630
GSK Investigational Site
Las Vegas, Nevada, 89113
About this study
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
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
- Being tested
- GSK3862995B, Placebo
- Keywords
- GSK3862995B, Chinese, Japanese, and European ancestry, Healthy Participants, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3862995BDrug
GSK3862995B will be administered.
PlaceboDrug
Matching placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK3862995B | Experimental | Participants of Chinese, Japanese, or European ancestries will receive GSK3862995B. Receives: Drug: GSK3862995B |
| Placebo | Experimental | Participants of Chinese, Japanese, or European ancestries will receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 36
Maximum Observed Concentration (Cmax) of GSK3862995B
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start20 May 2025
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, placebo-controlled, double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979518
- Sponsor's protocol ID
- 223982
- Status last verified
- Jun 2026
- First submitted
- 13 May 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06979518
- Acronym / sponsor ID
- 223982
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GSK3862995B, Chinese, Japanese, and European ancestry, Healthy Participants, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, placebo-controlled, double-blind study
| Arm | Type | Receives |
|---|---|---|
| GSK3862995B | Experimental | Drug: GSK3862995BParticipants of Chinese, Japanese, or European ancestries will receive GSK3862995B. |
| Placebo | Experimental | Drug: PlaceboParticipants of Chinese, Japanese, or European ancestries will receive matching placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3862995BGSK3862995B will be administered. | Drug | GSK3862995B |
| PlaceboMatching placebo will be administered. | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events (AE)
Time frame: Up to Week 44 (End of follow up visit)
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.
Number of Participants with Serious Adverse Events (SAE)
Time frame: Up to Week 44 (End of follow up visit)
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).
Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
Time frame: Up to Week 36
Number of Participants with clinically significant changes in clinical laboratory values (hematology, chemistry and urinalysis) will be assessed.
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Week 36
Number of Participants with clinically significant changes in vital signs will be assessed.
Number of Participants with Clinically Significant Changes in 12-lead (Electrocardiogram (ECG)
Time frame: Up to Week 36
Number of Participants with clinically significant changes in 12-lead ECG will be assessed.
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3862995B
Time frame: Up to Week 36
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Maximum Observed Concentration (Cmax) of GSK3862995B
Time frame: Up to Week 36
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3862995B in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE) (time frame: Up to Week 44 (End of follow up visit)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.