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

  • STATUS
    Recruiting
  • End date
    Mar 14, 2023
  • participants needed
    70
  • sponsor
    GlaxoSmithKline
Updated on 30 November 2021
body mass index
Accepts healthy volunteers

Summary

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.

Details
Condition Multiple Sclerosis, multiple sclerosis (ms), Dermatite Atopique modérée ou grave, Radiologically Isolated Syndrome
Treatment Placebo, GSK3888130B
Clinical Study IdentifierNCT05131971
SponsorGlaxoSmithKline
Last Modified on30 November 2021

Eligibility

Yes No Not Sure

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

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
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
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How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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