New lupus drug candidate begins first human safety tests
NCT ID NCT06188507
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is the first time a new drug, GSK4347859, is being tested in humans. The goal is to check its safety and how it behaves in the body. It involves 65 healthy adults and is currently on hold. The drug is being developed for lupus, an autoimmune disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Jul 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants who are overtly healthy. * Participant has a confirmed positive vaccination status for severe acute respiratory syndrome-related Coronavirus (2 SARS-CoV-2) and, if study dosing is during Flu season, influenza vaccines administered at least 30 days prior to dosing in the study. * Fitzpatrick skin type I, II or III (Part 2 only). * Body weight greater than or equal to (≥) 50 kilogram (kg) and body mass index (BMI) within the range 18 -32 kilogram per meter square (kg/m\^2) (inclusive). * Male and female of non-childbearing potential. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders. - Abnormal blood pressure * A clinically significant ECG abnormality at screening. * Evidence of active or latent tuberculosis (TB). * Symptomatic herpes zoster within 3 months prior to screening * Alanine transaminase (ALT) \>1 times upper limit of normal (ULN). * Total bilirubin \>1.5x ULN \[isolated total bilirubin \>1.5x ULN is acceptable if total bilirubin is fractionated and direct bilirubin \<35- percentage (%)\]. * History of malignancy. * Participants with known Corona virus disease-2019 (COVID-19) positive contacts as per local/site Guidelines * Prior moderate/severe COVID-19 infection requiring oxygen supplementation or admission to hospital. * Live vaccine(s) within 1 month prior to screening or plan to receive such vaccines during the study. * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing * The participant has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product and dosing. * Current enrolment or past participation in this clinical study * Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study * Positive pre-study drug/alcohol screen * Regular use of known drugs of abuse, including tetrahydrocannabinol. * Positive Human immunodeficiency virus (HIV) antibody test * Positive smoke breathalyzer levels indicative of smoking history at screening and each in-house admission to the clinical research unit or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * Estimated glomerular filtration rate (eGFR) of less than (\<) 90 (millilitre/minute) mL/min/1.73 m2 and / or Urine Albumin Creatinine (UACR) of \>30 milligram per gram (mg/g) at screening * A positive confirmation of SARS-CoV-2 infection or signs and symptoms suggestive of SARS-CoV-2 at screening or pre-dose * The participant has a phobia to needles * An average weekly alcohol intake of \> 14 units. For Part 2: * History of benign skin conditions including but not limited to photosensitivity, atopic dermatitis, chronic eczema, psoriasis, urticaria, vitiligo, post-inflammatory hyperpigmentation, or keloid or hypertrophic scaring that in the opinion of the Investigator would impact study participation. * History or presence of excessive bleeding or coagulation disorders. * History of adverse reaction to local anesthetic. * The presence of widespread acne, freckles, naevi, tattoos, birthmarks, piercings, scarring or other skin variations within the proposed Ultraviolet B (UVB) exposure challenge area * Direct UV exposure to the areas of the body to be studied within 2 weeks. * Unable to refrain from exposure to extended and direct sunlight or use of artificial tanning devices, self-tanning products, sun blocking products or other topical products (including moisturizers and makeup) on the areas of the body to be studied.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Systemic lupus erythematosus are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
GSK Investigational Site
Cambridge, CB2 2GG, United Kingdom
-
GSK Investigational Site
Nottingham, NG11 6JS, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ear-Zapping device may quiet lupus pain and fatigue
- Can a weekly dipstick at home catch lupus kidney damage early?
- Do rheumatic diseases quietly damage the Eye's oil glands?
- Can a blood test catch lupus flares earlier?
- Can one pill tame four autoimmune diseases? a Long-Term trial puts it to the test
- Can a single drug tame multiple autoimmune diseases?