ClinicalTrials.gg
RecruitingNCT07789899Updated Sep 1, 2026

A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants

A Phase 1 interventional study of GSK3862995B in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline — 7 open to participants now, 8 under way, 5 of them phase 3. Pulmonary Disease, Chronic Obstructive · GlaxoSmithKline.

Planned enrollment
184th of 236
24 · median 101
Started
2026
with 3 others
Phase 1
83 of 276
1 open now
Registered
275th of 276
by date

Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, this one is the 184th largest by planned enrollment of the 236 interventional ones that give a count, is one of 4 that started in 2026, is one of 83 in phase 1, and was the 275th registered.

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

7 of the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Who these studies take

Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.

03

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • GSK3862995B
  • Pharmacokinetics
  • Healthy Volunteers
  • Phase 1
  • Safety and Tolerability
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants who are generally healthy as determined by medical evaluation including 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
  • (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m\^2) (inclusive)
  • Male, or female of non- (PONCBP)

Exclusion criteria

Exclusion Criteria:

  • Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
  • A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
  • Abnormal blood pressure (as determined by the investigator)
  • Symptomatic herpes zoster within 3 months prior to screening
  • Significant allergies to humanized monoclonal antibodies
  • multiple or severe drug allergies, intolerance to topical , or severe post-treatment reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
  • Lymphoma, leukemia, or any within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of disease for 3 years
  • Breast cancer within the past 10 years
  • (ALT) greater than (>)1.0x (ULN)
  • Total >1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is less than or equal to (\<=) 1.5 x ULN
  • 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 readings performed at screening
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    GSK3862995B Formulation A

    Healthy participants will receive GSK3862995B Formulation A.

    Drug: GSK3862995B

  • Experimental
    GSK3862995B Formulation B

    Healthy participants will receive GSK3862995B Formulation B.

    Drug: GSK3862995B

Interventions

06

What researchers measure

Primary outcomes

  1. Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B

    Time frame: From pre-dose on Day 1 through Week 36

  2. Maximum Observed Serum Concentration (Cmax) of GSK3862995B

    Time frame: From pre-dose on Day 1 through Week 36

  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Week 49

  4. Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings

    Time frame: Up to Week 36

07

Study locations

1 of 1 sites recruiting
  • GSK Investigational Site
    Cambridge, CB2 2GG, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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/gsk-patient-level-data-sharing-july2025.pdf

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

Of 158 industry-sponsored phase 1 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's planned 12 months is above that.

Counting every sponsor, half of 176 studies reached it within 4 months; a quarter within 2 and three quarters within 11.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartActual
Aug 18, 2026
Primary completionEst.
Sep 7, 2027
CompletionEst.
Sep 7, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789899
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Aug 18, 2026
Primary completion
Sep 7, 2027 (estimated)
Completion
Sep 7, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: GSK3862995B

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