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Systemic Lupus ErythematosusPhase 1NCT06188507

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants

A Phase 1 study testing GSK4347859 in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 2 sites in United Kingdom.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
GSK4347859
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
2 sitesUnited Kingdom
Study dates
12 Jan 2024to 14 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 (%)].
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • GSK Investigational Site

    Cambridge, CB2 2GG

  • GSK Investigational Site

    Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3996401 Following Single and Multiple Ascending Doses of GSK4347859 in Healthy Participants

This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GSK4347859 in healthy participants. Part 1 consists of 2 planned cohorts with up to 4 treatment periods in each and is expected to have up to 8 dose levels. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels.

Being tested
GSK4347859, Placebo
Keywords
Lupus, GSK4347859, GSK3996401, Safety, First time in human (FTiH), Pharmacokinetics, Healthy Participants
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK4347859Drug

    GSK4347859 will be administered

  • PlaceboDrug

    Placebo will be administered

Study groups in NCT06188507
Study groupRoleWhat they receive
Part 1: Cohort 1-GSK4347859 or PlaceboExperimentalParticipants in Part 1 Cohort 1 will receive a single dose level of GSK4347859 dose level 1 or placebo in treatment period 1, followed by GSK4347859 dose levels 2 and 3 or placebo in 3- period dose escalation design. Additionally, there will be an optional 4th treatment period with dose level 4. Followed by a wash out period of at least 7 days between each dose.
Receives: Drug: GSK4347859; Drug: Placebo
Part 1: Cohort 2-GSK4347859 or PlaceboExperimentalParticipants in Part 1 Cohort 2 will receive a single dose level of GSK4347859 dose level 5 or placebo in treatment period 1, followed by GSK4347859 dose levels 6 and 7 or placebo in 3- period dose escalation design. Additionally, there will be an optional 4th treatment period with dose level 8. Followed by a wash out period of at least 7 days between each dose.
Receives: Drug: GSK4347859; Drug: Placebo
Part 2: Cohort 3-GSK4347859 or PlaceboExperimentalParticipants in Part 2 Cohort 3 will receive 14 days of repeat doses of GSK4347859 dose level A or placebo.
Receives: Drug: GSK4347859; Drug: Placebo
Part 2: Cohort 4-GSK4347859 or PlaceboExperimentalParticipants in Part 2 Cohort 4 will receive 14 days of repeat doses of GSK4347859 dose level B or placebo.
Receives: Drug: GSK4347859; Drug: Placebo
Part 2: Cohort 5-GSK4347859 or PlaceboExperimentalParticipants in Part 2 Cohort 5 will receive 14 days of repeat doses of GSK4347859 dose level C or placebo.
Receives: Drug: GSK4347859; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to Day 15

  2. Part 2 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to Day 30

  3. Part 1 - Number of Participants with Clinically Significant Changes in Haematology

    Measured: Up to Day 15

  4. Part 2 - Number of Participants with Clinically Significant Changes in Haematology

    Measured: Up to Day 30

  5. Part 1 - Number of Participants with Clinically Significant Changes in Clinical Chemistry

    Measured: Up to Day 15

  6. Part 2 - Number of Participants with Clinically Significant Changes in Clinical Chemistry

    Measured: Up to Day 30

  7. Part 1 - Number of Participants with Clinically Significant Changes in Laboratory Values for Urinalysis

    Measured: Up to Day 15

  8. Part 2 - Number of Participants with Clinically Significant Changes in Urinalysis

    Measured: Up to Day 30

  9. Part 1 - Number of Participants with Clinically Significant Changes in Vital Signs

    Measured: Up to Day 15

  10. Part 2 - Number of Participants with Clinically Significant Changes in Vital Signs

    Measured: Up to Day 30

  11. Part 1 - Number of Participants with Clinically Significant Changes in 12 Lead Electrocardiogram Readings

    Measured: Up to Day 15

  12. Part 2 - Number of Participants with Clinically Significant Changes in 12 Lead Electrocardiogram Readings

    Measured: Up to Day 30

  13. Part 1 - Number of Participants with Clinically Significant Changes in 24 Hour Telemetry

    Measured: Up to Day 2

  14. Part 2 - Number of Participants with Clinically Significant Changes in 24 Hour Telemetry

    Measured: Up to Day 15

Secondary outcomes (13)

  1. Part 1 - Maximum observed plasma concentration (Cmax) of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  2. Part 1 - Time to maximum observed plasma concentration (Tmax) of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  3. Part 1 - Apparent terminal half-life (t½) of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  4. Part 1 - Area under the concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  5. Part 1 - Area under the concentration-time curve from time zero to infinity [AUC(0-∞)] of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  6. Part 1 - Area under the concentration-time curve over each dosing interval [AUC(0-tau)] of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  7. Part 1 - Area under the concentration-time curve from time zero to 24 hours after dosing [AUC(0-24)] of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  8. Part 1 - Observed trough concentrations (Ctrough) of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 3

  9. Part 2 - Cmax of GSK3996401 following administration of single and repeat doses of GSK4347859

    Measured: Up to Day 15

  10. Part 2 - Tmax of GSK3996401 following administration of single and repeat doses of GSK4347859

    Measured: Up to Day 15

  11. Part 2 - Area under the concentration-time curve from time zero to 24 hours after dosing [AUC(0-24)] of GSK3996401 following administration single and repeat doses of GSK4347859

    Measured: Up to Day 15

  12. Part 2 - Observed trough concentrations (Ctrough) of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 15

  13. Part 2 - Area under the concentration-time curve over each dosing interval [AUC(0-tau)] of GSK3996401 following administration of GSK4347859

    Measured: Up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start12 Jan 2024
  3. Primary completion14 Jul 2026 (estimated)
  4. Study completion14 Jul 2026 (estimated)

Why it stopped: The trial was temporarily halted due to findings in new non-clinical studies necessitating further investigation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06188507
Sponsor's protocol ID
221220
Status last verified
Sep 2025
First submitted
19 Dec 2023
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK4347859 in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 15). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06188507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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