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New lupus drug candidate begins first human safety tests

NCT ID NCT06188507

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

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Other studies related to the condition(s) this trial covers.