NCT05174013 is a Phase 1 clinical trial of GSK3858279 in Pain, sponsored by GlaxoSmithKline.

Who is sponsoring NCT05174013?

NCT05174013 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT05174013?

Interventions in NCT05174013: GSK3858279, Placebo.

Is NCT05174013 still recruiting?

NCT05174013 is currently completed. Last updated 15 May 2025.

Are results published for NCT05174013?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-15 · How we verify

NCT05174013

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 15 May 2025

What this trial tests

Phase 1 trial testing GSK3858279 in Pain in 33 participants. Completed in 17 April 2023.

Timeline

14 February 2022

Primary endpoint
10 February 2023

17 April 2023

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	33
Start date	14 February 2022
Primary completion	10 February 2023
Estimated completion	17 April 2023
Sites	2 locations across Australia

Drugs / interventions tested

GSK3858279 — full drug profile →
Placebo

Conditions studied

Pain — all drugs for Pain →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 65, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's Primary · Up to 169 days

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for C

Group	Value	95% CI
GSK3858279 Caucasian	5
GSK3858279 Chinese	6
GSK3858279 Japanese	2
Caucasian Placebo	4
Chinese Placebo	1
Japanese Placebo	2

SAE

Group	Value	95% CI
GSK3858279 Caucasian	0
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Withdrawals Due to AE

Group	Value	95% CI
GSK3858279 Caucasian	0
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Change From Baseline in Hematology Parameter of Platelet Count Primary · Baseline and Day 169

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Group	Value	95% CI
GSK3858279 Caucasian	2.8	± 25.90
GSK3858279 Chinese	18.0	± 18.81
GSK3858279 Japanese	-4.2	± 12.27
Caucasian Placebo	7.0	± 15.59
Chinese Placebo	16.0	± 39.60
Japanese Placebo	-12.3	± 6.51

Change From Baseline in Hematology Parameter of Hemoglobin Primary · Baseline and Day 169

Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Group	Value	95% CI
GSK3858279 Caucasian	-7.5	± 13.79
GSK3858279 Chinese	-6.0	± 10.42
GSK3858279 Japanese	-2.0	± 10.79
Caucasian Placebo	-5.3	± 7.37
Chinese Placebo	-10.5	± 16.26
Japanese Placebo	-3.0	± 3.61

Change From Baseline in Hematology Parameter of Hematocrit Primary · Baseline and Day 169

Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Group	Value	95% CI
GSK3858279 Caucasian	-0.027	± 0.0367
GSK3858279 Chinese	-0.010	± 0.0408
GSK3858279 Japanese	-0.005	± 0.0259
Caucasian Placebo	-0.027	± 0.0321
Chinese Placebo	-0.035	± 0.0495
Japanese Placebo	-0.013	± 0.0208

Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Primary · Baseline and Day 169

Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Basophils

Group	Value	95% CI
GSK3858279 Caucasian	0.01	± 0.020
GSK3858279 Chinese	0.00	± 0.000
GSK3858279 Japanese	0.00	± 0.000
Caucasian Placebo	0.00	± 0.00
Chinese Placebo	-0.03	± 0.035
Japanese Placebo	0.00	± 0.000

Eosinophils

Group	Value	95% CI
GSK3858279 Caucasian	0.00	± 0.084
GSK3858279 Chinese	-0.03	± 0.035
GSK3858279 Japanese	0.02	± 0.135
Caucasian Placebo	-0.07	± 0.115
Chinese Placebo	0.03	± 0.035
Japanese Placebo	0.68	± 1.098

Lymphocytes

Group	Value	95% CI
GSK3858279 Caucasian	0.02	± 0.172
GSK3858279 Chinese	0.10	± 0.141
GSK3858279 Japanese	0.04	± 0.261
Caucasian Placebo	0.03	± 0.306
Chinese Placebo	0.15	± 0.212
Japanese Placebo	-0.20	± 0.361

Monocytes

Group	Value	95% CI
GSK3858279 Caucasian	0.00	± 0.063
GSK3858279 Chinese	0.05	± 0.071
GSK3858279 Japanese	0.10	± 0.122
Caucasian Placebo	-0.10	± 0.265
Chinese Placebo	0.05	± 0.071
Japanese Placebo	0.10	± 0.100

Neutrophils

Group	Value	95% CI
GSK3858279 Caucasian	-0.12	± 0.791
GSK3858279 Chinese	-0.25	± 0.212
GSK3858279 Japanese	0.54	± 1.001
Caucasian Placebo	-0.97	± 1.079
Chinese Placebo	1.15	± 1.061
Japanese Placebo	0.07	± 0.462

Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Primary · Baseline and Day 169

Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Alkaline Phosphatase (AP)

Group	Value	95% CI
GSK3858279 Caucasian	0.8	± 12.16
GSK3858279 Chinese	1.3	± 6.34
GSK3858279 Japanese	-6.5	± 14.18
Caucasian Placebo	0.0	± 7.94
Chinese Placebo	-3.0	± 8.49
Japanese Placebo	-4.3	± 11.06

Alanine Aminotransferase (ALT)

Group	Value	95% CI
GSK3858279 Caucasian	3.2	± 9.70
GSK3858279 Chinese	9.3	± 17.25
GSK3858279 Japanese	4.0	± 4.15
Caucasian Placebo	17.3	± 5.13
Chinese Placebo	-3.0	± 5.66
Japanese Placebo	-2.0	± 11.79

Aspartate Aminotransferase (AST)

Group	Value	95% CI
GSK3858279 Caucasian	2.3	± 5.72
GSK3858279 Chinese	12.0	± 19.37
GSK3858279 Japanese	0.8	± 6.74
Caucasian Placebo	11.0	± 3.61
Chinese Placebo	1.0	± 4.24
Japanese Placebo	-1.3	± 3.06

Change From Baseline in Clinical Chemistry Parameter of Total Protein Primary · Baseline and Day 169

Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Group	Value	95% CI
GSK3858279 Caucasian	2.2	± 1.94
GSK3858279 Chinese	2.5	± 2.89
GSK3858279 Japanese	0.8	± 4.45
Caucasian Placebo	0.3	± 2.52
Chinese Placebo	-0.5	± 4.95
Japanese Placebo	3.3	± 1.53

Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin Primary · Baseline and Day 169

Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Group	Value	95% CI
GSK3858279 Caucasian	-5.3	± 3.88
GSK3858279 Chinese	-0.3	± 4.79
GSK3858279 Japanese	-1.5	± 3.73
Caucasian Placebo	-4.7	± 1.53
Chinese Placebo	0.5	± 2.12
Japanese Placebo	1.3	± 6.03

Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine Primary · Baseline and Day 169

Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Direct Bilirubin,

Group	Value	95% CI
GSK3858279 Caucasian	-1.8	± 1.47
GSK3858279 Chinese	0.0	± 2.16
GSK3858279 Japanese	-0.3	± 0.82
Caucasian Placebo	-1.7	± 0.58
Chinese Placebo	0.0	± 1.41
Japanese Placebo	1.3	± 3.51

Creatinine

Group	Value	95% CI
GSK3858279 Caucasian	1.8	± 8.86
GSK3858279 Chinese	-1.8	± 8.85
GSK3858279 Japanese	3.0	± 4.94
Caucasian Placebo	5.7	± 10.69
Chinese Placebo	14.5	± 7.78
Japanese Placebo	0.0	± 3.61

Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium Primary · Baseline and Day 169

Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Glucose

Group	Value	95% CI
GSK3858279 Caucasian	0.25	± 0.575
GSK3858279 Chinese	0.03	± 0.171
GSK3858279 Japanese	0.18	± 0.549
Caucasian Placebo	0.23	± 0.651
Chinese Placebo	1.10	± 1.980
Japanese Placebo	0.27	± 0.208

Potassium

Group	Value	95% CI
GSK3858279 Caucasian	0.00	± 0.400
GSK3858279 Chinese	-0.08	± 0.189
GSK3858279 Japanese	-0.15	± 0.302
Caucasian Placebo	0.33	± 0.115
Chinese Placebo	-0.45	± 0.212
Japanese Placebo	0.03	± 0.058

Sodium

Group	Value	95% CI
GSK3858279 Caucasian	1.8	± 0.98
GSK3858279 Chinese	-1.8	± 3.40
GSK3858279 Japanese	0.5	± 3.02
Caucasian Placebo	0.7	± 1.53
Chinese Placebo	0.0	± 1.41
Japanese Placebo	1.0	± 0.00

Urea

Group	Value	95% CI
GSK3858279 Caucasian	1.43	± 0.907
GSK3858279 Chinese	0.38	± 1.715
GSK3858279 Japanese	0.87	± 1.718
Caucasian Placebo	1.03	± 0.862
Chinese Placebo	1.45	± 0.495
Japanese Placebo	1.13	± 0.723

Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density) Primary · Baseline and Day 169

Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-miss

Any Increase

Group	Value	95% CI
GSK3858279 Caucasian	6
GSK3858279 Chinese	7
GSK3858279 Japanese	7
Caucasian Placebo	4
Chinese Placebo	3
Japanese Placebo	4

Increase to 1.019

Group	Value	95% CI
GSK3858279 Caucasian	0
GSK3858279 Chinese	0
GSK3858279 Japanese	1
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Increase to 1.02

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Increase to 1.021

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	1
Chinese Placebo	0
Japanese Placebo	0

Increase to 1.024

Group	Value	95% CI
GSK3858279 Caucasian	0
GSK3858279 Chinese	0
GSK3858279 Japanese	2
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Increase to 1.025

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	1
GSK3858279 Japanese	0
Caucasian Placebo	1
Chinese Placebo	0
Japanese Placebo	0

Increase to 1.026

Group	Value	95% CI
GSK3858279 Caucasian	0
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	1
Chinese Placebo	0
Japanese Placebo	0

Increase to 1.027

Group	Value	95% CI
GSK3858279 Caucasian	0
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	1
Japanese Placebo	0

Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Primary · Baseline and Day 169

Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 1

Any Increase

Group	Value	95% CI
GSK3858279 Caucasian	5
GSK3858279 Chinese	6
GSK3858279 Japanese	4
Caucasian Placebo	2
Chinese Placebo	2
Japanese Placebo	3

Increase to 6.5

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	2
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Increase to 7.0

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	1

Increase to 7.5

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	2
GSK3858279 Japanese	2
Caucasian Placebo	0
Chinese Placebo	2
Japanese Placebo	2

Increase to 8.0

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	2
GSK3858279 Japanese	2
Caucasian Placebo	2
Chinese Placebo	0
Japanese Placebo	0

Increase to 8.5

Group	Value	95% CI
GSK3858279 Caucasian	1
GSK3858279 Chinese	0
GSK3858279 Japanese	0
Caucasian Placebo	0
Chinese Placebo	0
Japanese Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs and SAEs were collected from the start of the study intervention up to Day 169.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK3858279 Caucasian

Serious: 0/6 (0%)

Deaths: 0/6

GSK3858279 Chinese

Serious: 0/7 (0%)

Deaths: 0/7

GSK3858279 Japanese

Serious: 0/7 (0%)

Deaths: 0/7

Caucasian Placebo

Serious: 0/4 (0%)

Deaths: 0/4

Chinese Placebo

Serious: 0/3 (0%)

Deaths: 0/3

Japanese Placebo

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (23 terms — click to expand)

Reaction	System	GSK3858279 Caucasian	GSK3858279 Chinese	GSK3858279 Japanese	Caucasian Placebo	Chinese Placebo	Japanese Placebo
COVID-19	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Conjunctival hyperaemia	Eye disorders	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Skin candida	Infections and infestations	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Eyelid injury	Injury, poisoning and procedural complications	—	—	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Costochondritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Tendonitis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Sedation	Nervous system disorders	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—
Skin irritation	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT05174013 adverse events section.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of GSK3858279

Trials testing the same drug.

NCT05838755 — A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain · Phase 2 · terminated
NCT05838742 — A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain · Phase 2 · terminated
NCT04114656 — Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers · Phase 1 · terminated

Other recruiting trials for Pain

Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05174013 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 15 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05174013.

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