NCT06154837Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 127 (actual)
- First submitted
- 26 Nov 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 17 Dec 2026
- Lead sponsor
- GlaxoSmithKline
- Diseases
- COPD
- NCT number
- NCT06154837
- EU CT number
- 2023-506880-32-01
- EudraCT number
- 2023-506880-32
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 127
- From 27 Nov 2023 to the primary completion date, 17 Dec 2026
- 33 sites in 3 countries
- 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, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia, tuberculosis, hepatitis B, shingles).
Other illness
- 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.
- 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
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Lab values
- Alanine transaminase (ALT) \>1x upper limit of normal (ULN)
- Total bilirubin \>1.5xULN (isolated total bilirubin \>1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (\<) 35%).
Other
- A clinically significant abnormality in 12-lead ECG readings performed at screening
- A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).
Who the study is looking for
- Healthy participants (Part A)
- Participant must be 18 to 65 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight within the range 50-110 kilogram (kg) (inclusive)
- Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m\^2)
- Male and/or female of non-childbearing potential
- Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B)
- Participant must be 40 to 75 years of age inclusive.
- Body weight within the range 50-110 kg (inclusive)
- BMI within the range 19.5-32 kg/m\^2
- Participant has a confirmed diagnosis of COPD for greater than (\>)12 months
- Participants must present with a measured post-salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (\<) 0.70 at screening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1 greater than or equal to (\>=) 40% of predicted normal values.
- Participants must have a well-documented requirement for optimized standard of care background therapy that includes daily inhaled medication.
- A peripheral blood eosinophil count of \>=150 cells/microliter (mcL) at screening
- Former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at screening current smokers (includes the use of any type of nicotine containing product), or non-smokers are permitted
- Male and/or female of non-childbearing potential.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Ahrensburg | Germany | Active, not recruiting |
| Klinische Forschung Berlin-Mitte GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Parexel International GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Klinische Forschung Dresden GmbH Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Active, not recruiting |
| Hamburger Institut fuer Therapieforschung GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Klinische Forschung Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Klinische Forschung Hannover-Mitte GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Active, not recruiting |
| Klinische Forschung Karlsruhe GmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Active, not recruiting |
| Salvus-Klinische Studien GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Luebeck | Germany | Active, not recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Pneumologisches Studienzentrum München-West, Gemeinschaftspraxis fuer Lungen- und Bronchialheilkunde Coordinator of this site? Confirm its status | Muenchen | Germany | Active, not recruiting |
| Klinische Forschung Schwerin GmbH Coordinator of this site? Confirm its status | Schwerin | Germany | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Barnsley | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Cannock | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | West Yorkshire | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rock Hill | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Shelby | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Yuma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.