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Phase 1 Completed N=31 Randomized Double-blind Treatment

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants

Pain
Source: ClinicalTrials.gov NCT05174013 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's — 5; 6; 2; 4 Participants

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's
5; 6; 2; 4; 1; 2
PRIMARY
Change From Baseline in Hematology Parameter of Platelet Count
2.8; 18.0; -4.2; 7.0; 16.0; -12.3
PRIMARY
Change From Baseline in Hematology Parameter of Hemoglobin
-7.5; -6.0; -2.0; -5.3; -10.5; -3.0
PRIMARY
Change From Baseline in Hematology Parameter of Hematocrit
-0.027; -0.010; -0.005; -0.027; -0.035; -0.013
PRIMARY
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
0.01; 0.00; 0.00; 0.00; -0.03; 0.00
PRIMARY
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)
0.8; 1.3; -6.5; 0.0; -3.0; -4.3
PRIMARY
Change From Baseline in Clinical Chemistry Parameter of Total Protein
2.2; 2.5; 0.8; 0.3; -0.5; 3.3
PRIMARY
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin
-5.3; -0.3; -1.5; -4.7; 0.5; 1.3
PRIMARY
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine
-1.8; 0.0; -0.3; -1.7; 0.0; 1.3
PRIMARY
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium
0.25; 0.03; 0.18; 0.23; 1.10; 0.27
PRIMARY
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)
6; 7; 7; 4; 3; 4
PRIMARY
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)
5; 6; 4; 2; 2; 3
PRIMARY
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
1; 1; 1; 0; 0; 0
PRIMARY
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
5.3; 0.8; 0.8; -1.0; 5.0; 0.0
PRIMARY
Change From Baseline in Vital Signs: Pulse Rate
6.5; 16.0; 6.8; 6.7; 10.0; 4.3
PRIMARY
Change From Baseline in Vital Signs: Body Temperature
0.07; -0.03; 0.48; -0.10; 0.00; -0.03
PRIMARY
Change From Baseline in Vital Signs: Respiratory Rate
-0.5; -0.8; -1.0; -2.0; -0.5; -0.7
PRIMARY
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
-5.000; -4.000; -7.889; -15.778; -8.167; 6.111
PRIMARY
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279
87592.7; 86412.2; 77742.0
PRIMARY
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279
88679.6; 87201.8; 77009.4
PRIMARY
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279
56.115; 56.062; 55.964
PRIMARY
Maximum Observed Concentration (Cmax) of GSK3858279
9135.3; 6851.4; 8295.4
PRIMARY
Time of Occurrence of Cmax (Tmax) of GSK3858279
2.004; 3.919; 3.217
SECONDARY
Percentage Change From Baseline in Free CCL17
89.715; 85.825; 88.461; 22.353; 0.452; 0.863
SECONDARY
Cmax of Total CCL17 in Serum Following GSK3858279
68969.794; 62648.760; 55177.740; 1661.847; 733.904; 621.421
SECONDARY
Tmax of Total CCL17 in Serum Following GSK3858279
9.333; 14.000; 8.571; 57.000; 1.083; 26.313
SECONDARY
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration
77.479; 113.436; 73.474; 1.155; 1.270; 1.383
SECONDARY
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration
76.489; 93.537; 70.025; 0.866; 0.975; 1.025
SECONDARY
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)
0; 0; 0; 0; 0; 0
SECONDARY
Number of Participants With Treatment-Emergent ADA's Over Time
0; 0; 0; 0; 0; 0

Eligibility 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 ( )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 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, co
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05174013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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