Last updated: 09/01/2025 05:30:14

Safety, tolerability, pharmacokinetics and target engagement of GSK3858279 in healthy Caucasian, Chinese and Japanese participants

GSK study ID
212979
See study documents
Clinicaltrials.gov ID
NCT05174013
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a single subcutaneous dose of GSK3858279 administered to Healthy Caucasian, Chinese and Japanese Participants
Trial description: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy Caucasian, Chinese and Japanese participants.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number Of Participants with Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's

Timeframe: Up to 169 days

Change From Baseline in Hematology Parameter of Platelet Count

Timeframe: Baseline and Day 169

Change From Baseline in Hematology Parameter of Hemoglobin

Timeframe: Baseline and Day 169

Change From Baseline in Hematology Parameter of Hematocrit

Timeframe: Baseline and Day 169

Change From Baseline in White Blood Cell (Wbc) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Timeframe: Baseline and Day 169

Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)

Timeframe: Baseline and Day 169

Change From Baseline in Clinical Chemistry Parameter of Total Protein

Timeframe: Baseline and Day 169

Change from Baseline in Clinical Chemistry Parameter of Total Bilirubin

Timeframe: Baseline and Day 169

Change from Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine

Timeframe: Baseline and Day 169

Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium

Timeframe: Baseline and Day 169

Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)

Timeframe: Baseline and Day 169

Change from Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)

Timeframe: Baseline and Day 169

Number of Participants With Abnormal Urinalysis Results by Dipstick Method

Timeframe: Baseline and Day 169

Change from Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Timeframe: Baseline and Day 169

Change from Baseline in Vital Signs: Pulse Rate

Timeframe: Baseline and Day 169

Change from Baseline in Vital Signs: Body Temperature

Timeframe: Baseline and Day 169

Change from Baseline in Vital Signs: Respiratory Rate

Timeframe: Baseline and Day 169

Change from Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval

Timeframe: Baseline and Day 169

Area Under the Plasma Concentration-Time Curve from Time Zero to 56 Days AUC (0-56)] of GSK3858279

Timeframe: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57

AUC from Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279

Timeframe: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Time of Occurrence of Last Quantifiable Concentration (tlast) of GSK3858279

Timeframe: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Maximum Observed Concentration (Cmax) of GSK3858279

Timeframe: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Time of Occurrence of Cmax (tmax) of GSK3858279

Timeframe: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Secondary outcomes:

Percentage Change from Baseline in Free CCL17

Timeframe: Baseline and at Day 7, Day 14, Day 28 and Day 56 Post dose

Cmax of Total CCL17 in Serum Following GSK3858279

Timeframe: Baseline and at Day 7, Day 14, Day 28 and Day 56 Post dose

Tmax of Total CCL17 in Serum Following GSK3858279

Timeframe: Baseline and at Day 7, Day 14, Day 28 and Day 56 Post dose

Maximum Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration

Timeframe: Baseline and at Day 7, Day 14, Day 28 and Day 56 Post dose

Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration

Timeframe: Baseline and at Day 7, Day 14, Day 28 and Day 56 Post dose

Number of Participants with Pre-existing Anti-drug Antibodies (ADA's)

Timeframe: Day 169

Number of Participants with Treatment-Emergent ADA's Over Time

Timeframe: Day 169

Interventions:
  • Drug: GSK3858279
  • Drug: Placebo
    • Enrollment:
    33
    Primary completion date:
    2023-10-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pain
    Product
    GSK3858279
    Collaborators
    NA
    Study date(s)
    February 2022 to April 2023
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 65 Years
    Accepts healthy volunteers
    Yes
    • Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
    • Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
    • Personal or family history of cardiomyopathy.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
    • Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
    • Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    • Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
    • Body weight within the range 45 – 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive).
    • Japanese participants are eligible based on meeting all of the following:
    • Participants born in Japan
    • Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents.
    • Have lived outside Japan for less than (<) 10 years at the time of screening
    • Chinese participants are eligible based on meeting all of the following
    • Participants born in mainland China, Hong Kong or Taiwan
    • Descendants of four Chinese grandparents and two Chinese parents
    • Have lived outside China, Hong Kong or Taiwan for <10 years at the time of screening
    • Caucasian participants are eligible based on meeting the following
    • Declaration of familial Caucasian/European ancestry (having 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry)
    • Male or female participant
    • Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
    • A female participant is eligible to participate if she is of non-reproductive potential.
    • Capable of giving signed informed consent.
    Exclusion criteria:
    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
    • Personal or family history of cardiomyopathy.
    • Abnormal blood pressure at screening as determined by the investigator.
    • History of symptomatic herpes zoster.
    • Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
    • Significant allergies to humanized monoclonal antibodies as per principal investigator’s and GSK medical monitor’s judgements.
    • History or evidence of 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).
    • History of lymphoma, leukaemia, or any malignancy within the last 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. ALT greater than (>)1.5 times upper limit of normal (ULN) .
    • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    • Corrected QT (QTc) >450 milliseconds (msec).
    • History of Stevens Johnson Syndrome.
    • Known immunodeficiency.
    • Participants with a chronic infection (for example [e.g.], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
    • Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders.
    • History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments.
    • Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit.
    • Live vaccine(s) or plans to receive such vaccines within 1 month of screening until final follow-up visit.
    • Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
    • Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
    • Major surgery (as per investigator’s judgement) within 3 months prior to dosing.
    • Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months.
    • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
    • Current enrolment or past participation in any other clinical study involving an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing the ICF.
    • Presence of Hepatitis B surface antigen (HBsAg) at screening.
    • Presence of the Hepatitis B core antibody (HBcAb) at screening.
    • Positive Hepatitis C antibody test result at screening.
    • Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
    • Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
    • Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening.
    • Positive pre-study drug/alcohol screen.
    • Positive human immunodeficiency virus (HIV) antibody test.
    • Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction (PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab only.
    • Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 units for males and >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
    • Regular use of known drugs of abuse.
    • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Herston Queensland, QLD, Australia, 4006
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Melbourne, VIC, Australia, 3004
    Status
    Study Complete
    Contact us

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2023-10-02
    Actual study completion date
    2023-17-04

    Plain language summaries

    Summary of results in plain language
    Available language(s): Chinese (Simplified), English, Japanese
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    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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