GSK Investigational Medicine GSK3862995B: two formulations in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study compares two formulations of the investigational drug GSK3862995B in healthy volunteers. It aims to characterize pharmacokinetics—how the body absorbs, distributes, metabolizes, and excretes the drug—while monitoring safety and tolerability. Eligible participants are generally healthy adults meeting specific weight, BMI, and non-childbearing status criteria. The study is sponsored by GlaxoSmithKline and conducted at a dedicated GSK investigational site in Cambridge.

Why it matters

Who can join: the full rules

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
* Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m\^2) (inclusive)
* Male, or female of non-childbearing potential (PONCBP)

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, hepatitis B 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
* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
* 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
* Alanine transaminase (ALT) greater than (\>)1.0x upper limit of normal (ULN)
* Total bilirubin \>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 ECG readings performed at screening

Where it's running

• GSK Investigational Site
  Cambridge, United Kingdom Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ensa?fentrine to help prevent COPD flare-ups in adults on standard care

  This study tests whether ensifentrine (MK-5884) can help prevent moderate or severe COPD exacerbations compared with placebo in adults already receiving standard COPD treatment.

  Recruiting at 7 sites Phase 3 Merck Sharp & Dohme LLC · Hialeah Gardens, Florida and 6 other locations · NCT07874815

• GSK5784283 added to standard COPD therapy vs placebo in moderate to very severe COPD

  This study tests whether adding GSK5784283 to current COPD treatment reduces the rate of COPD flare-ups in adults with eosinophilic COPD and a history of exacerbations.

  Recruiting at 7 sites Phase 3 GlaxoSmithKline · Doral, Florida and 6 other locations · NCT07780669

• GSK5784283 added to standard COPD care versus placebo in adults with moderate to very severe COPD

  This study tests whether adding GSK5784283 to a patient’s current COPD treatment helps reduce COPD flare-ups compared with a placebo in adults with eosinophilic COPD and a history of frequent exacerbations.

  Recruiting at 8 sites Phase 3 GlaxoSmithKline · Cape Coral, Florida and 7 other locations · NCT07780656

• Brenipatide for adults with moderate-to-severe COPD

  This study tests different doses of Brenipatide to see if it is safe and effective for adults with moderate-to-severe COPD, compared with placebo.

  Recruiting at 69 sites Phase 2 Eli Lilly and Company · Birmingham, Alabama and 126 other locations · NCT07759245

• Early depemokimab treatment for COPD with type 2 (eosinophilic) inflammation

  This trial will test whether adding depemokimab early to standard care helps adults with moderate-to-severe COPD who have type 2 (eosinophilic) inflammation.

  Recruiting at 121 sites Phase 3 GlaxoSmithKline · Newport Beach, California and 120 other locations · NCT07177339

• Depemokimab for adults with COPD and eosinophilic (type 2) inflammation

  This study will test whether adding depemokimab to usual inhaled therapy can reduce flare-ups and improve outcomes for adults (40–80) with moderate-to-severe COPD and high blood eosinophils.

  Recruiting at 193 sites Phase 3 GlaxoSmithKline · Sheffield, Alabama and 192 other locations · NCT06961214

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.