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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants

Study Purpose

This is a first time in human study designed to assess the safety, tolerability, pharmacokinetics and PD of GSK3888130B over a range of dose levels in healthy participants.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participant must be 18 to 55 years of age inclusive.
  • - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • - Participants with a confirmed positive vaccination status for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines administered at least 30 days prior to dosing in the study.
  • - SARS-CoV-2 screening test negative as per local guidance.
  • - Participants with history of current/seasonal vaccination status for influenza or who consent to receive influenza vaccine at least 30 days prior to dosing, if study dosing is during influenza season (1st October to 30th April).
  • - Body weight greater than or equal to (>=) 50 kilograms (kg) and body mass index (BMI) within the range 19.5-32 kilograms per square meter (kg/m^2) (inclusive).
  • - Male and/or female of non-childbearing potential.
  • - Capable of giving signed informed consent.
  • - Additional inclusion criteria for Immune Challenge Model Cohorts: Participants with a history of Bacillus Calmette Guerin (BCG) vaccination as evidenced by a BCG scar or documented medical history of a BCG vaccination with/without a BCG scar.
Verbal communication of BCG vaccination from the participant will be acceptable if documentation is not available or a BCG scar is not visible and recorded in the source notes.

Exclusion Criteria:

  • - Prior medical history of anaphylaxis.
  • - Immunodeficiency or autoimmunity assessed by medical history.
  • - A history of recurrent infections.
  • - Treatment of a chronic infection within 3 months prior to the first dose of study drug.
  • - Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks of dosing.
  • - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
  • - Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  • - Participants with a history of renal disease or renal abnormalities.
  • - A clinically significant abnormality in the 12-lead ECG performed at screening.
  • - A clinically significant abnormality in the Holter monitor performed at screening.
  • - History of malignancy, including malignant or non-malignant skin cancer.
  • - Participants with known SARS-CoV-2 positive contacts in the past 14 days.
  • - Prior moderate/severe SARS-CoV-2 infection requiring oxygen supplementation or admission to hospital.
  • - Antibiotics or antiviral therapy within 30 days of dosing.
  • - Receipt of live vaccination within 30 days of dosing or plan to receive live vaccination during the study.
  • - Use of prescription drugs or non-prescription drugs, including non-steroidal anti inflammatory drug (NSAIDs), within 7 days prior to dosing, if in the opinion of the Investigator (in consultation with the GlaxoSmithKline [GSK] Medical Monitor if required) the medication will interfere with the study procedures or compromise participant safety.
  • - The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • - Exposure to more than 4 new chemical entities within 12 months prior to dosing.
  • - A positive drug/alcohol test at screening or Day -1.
  • - The participant is at high-risk of Mycobacterium tuberculosis (MTB) infection in the opinion of the Investigator.
  • - Additional exclusion criteria for Immune Challenge Model Cohorts: History of a severe local reaction to tuberculin products.
  • - History of asthma, allergic rhinitis or atopic dermatitis defined by the need for intermittent or continuous therapy or any other significant allergies that, in the opinion of the investigator contraindicates their participation.
  • - History of severe adverse reaction to local anesthetic.
  • - Presence of keloids or history of keloids.
  • - Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5x upper limit of normal (ULN) at screening.
  • - History or presence of excessive bleeding or coagulation disorders that in the opinion of the Investigator poses a safety risk with regards to participation in the trial.
  • - Presence of tattoos, naevi or other skin abnormalities on the volar forearm Fitzpatrick skin color grades V in the opinion of the investigator, interfere with study assessments.
  • - Participating, within 7 days of dosing, in recreational sun-bathing, or use of sunbed, on the area of the skin from wrist to shoulder inclusive.
  • - Current smoker or user of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) during or within 30 days prior to study participation.
  • - An average weekly intake of >14 units of alcohol.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05131971
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GlaxoSmithKline
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

GSK Clinical Trials
Principal Investigator Affiliation GlaxoSmithKline
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Arms & Interventions

Arms

Experimental: Cohort 1: Participants receiving GSK3888130B at dose level 1

Placebo Comparator: Cohort 1: Participants receiving placebo

Experimental: Cohort 2: Participants receiving GSK3888130B at dose level 2

Placebo Comparator: Cohort 2: Participants receiving placebo

Experimental: Cohort 3: Participants receiving GSK3888130B at dose level 3

Placebo Comparator: Cohort 3: Participants receiving placebo

Experimental: Cohort 4: Participants receiving GSK3888130B at dose level 4

Placebo Comparator: Cohort 4: Participants receiving placebo

Experimental: Cohort 5: Participants receiving GSK3888130B at dose level 5

Placebo Comparator: Cohort 5: Participants receiving placebo

Experimental: Cohort 6: Participants receiving GSK3888130B at dose level 6

Placebo Comparator: Cohort 6: Participants receiving placebo

Experimental: Cohort 7: Participants receiving GSK3888130B at dose level 7

Placebo Comparator: Cohort 7: Participants receiving placebo

Interventions

Drug: - GSK3888130B

GSK3888130B will be administered.

Drug: - Placebo

Placebo will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

GSK Investigational Site, Cambridge, United Kingdom

Status

Recruiting

Address

GSK Investigational Site

Cambridge, , CB2 2GG

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

Nearest Location

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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