Colitis, UlcerativePhase 1NCT06681181
A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants
A Phase 1 study testing GSK4528287 in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- GSK4528287
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2024to 11 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- White blood cell greater than or equal to (>=) lower limit of normal (LLN), including both lymphocyte counts >= LLN and neutrophil counts >= LLN, at both screening and pre-dose (Day-1) Note: in cases where the test is abnormal, the participant may have the test repeated once and if their second test is normal, they will be eligible. In the event a second test is also abnormal, the participant is not eligible
- Electrocardiogram (ECG) with no clinically significant abnormality at the discretion of the investigator/designee
- Participants with a confirmed positive vaccination status for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines as per local/site guidance
- SARS-CoV-2 screening test negative as per local guidance
- If dosing is during influenza season (October to April per local guidelines), participants who have not had a seasonal influenza vaccine must receive a medicines and healthcare products regualtory agency (MHRA)-approved influenza vaccine at least 30 days before dosing
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- Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 18-32 kilograms per square meters (kg/m^2) (inclusive)
- Male and/or female of non-childbearing potential
- Male participants are eligible to participate if they agree to the following during the study intervention period and for 48 weeks after the single dose of study intervention: refrain from donating sperm; be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
- A female participant is eligible to participate if she is a woman of non-childbearing potential (WONCBP)
- Capable of giving signed informed consent
Who cannot join
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- Abnormal blood pressure as determined by the investigator
- Symptomatic herpes zoster within 3 months prior to screening
- Prior medical history of anaphylaxis or severe adverse reactions to vaccines
- Significant allergies to humanized monoclonal antibodies
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
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- Immunodeficiency or autoimmunity assessed by medical history.
- A history of recurrent infections
- Treatment of any significant infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, shingles)
- Any history of chronic infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Any acute infection (including upper respriatory tract infection [URTI] and urinary tract infection [UTI]) which has not fully resolved within four weeks of dosing
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) medical monitor, poses a safety risk with regards to participation in the trial
- History of malignancy, including malignant or non-malignant skin cancer
- Prior moderate/severe SARS-CoV-2 infection requiring oxygen supplementation or admission to hospital
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Antibiotics or antiviral therapy within 30 days of dosing
- Receipt of live vaccination within 1 month prior to screening or plan to receive live vaccination 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 (IP) within the following time-period prior to the first dosing day of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- Exposure to more than 4 new chemical entities within 12 months prior to dosing
- Current enrolment or past participation in this clinical study.
- Participation in a clinical study that would result in donation of blood or blood products in excess of 500 millilitres (mL) within a 56 day period
- A positive diagnostic Mycobacterium tuberculosis bacteria (MTB) test at screening (defined as positive QuantiFERON Gold test)
- Positive test for HIV antibody at screening
- Positive drug/alcohol test, including tetrahydrocannabinol, at screening or Day 1
- Positive smoke breath analyzer levels indicative of smoking history at screening and in house admission to the clinical research unit or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches, vaporizing devices) within 6 months prior to 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 is at high risk of MTB infection in the opinion of the Investigator. Risk factors include residing in a high prevalence area or having close contact with a person with confirmed MTB infection
- The participant has a phobia to needles
- Regular alcohol consumption within 6 months prior to study, defined as: An average weekly intake of greater than (>)14 units of alcohol. One unit is equivalent to 8 grams (g) of alcohol: a half pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits
- Regular use of known drugs of abuse, including tetrahydrocannabinol
- Alanine aminotransferase (ALT or AST) >1.0*upper limit of normal (ULN)
- Total bilirubin >1.0*ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5*ULN as long as direct bilirubin is less than or equal to (<=) 1.5*ULN
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or Day -1 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 intervention.
- QTcF (QT interval corrected for heart rate according to Fredericia's formula) >450 milliseconds (msec).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants
"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. The study will test single doses of GSK4528287 to check for side effects, measure blood levels, and understand how it works in the body. The study will start with a small dose, and the dose will be increased for each new group of participants."
- Conditions
- Colitis, Ulcerative
- Being tested
- GSK4528287, Placebo
- Keywords
- Inflammatory bowel disease, Crohns disease, Ulcerative colitis, GSK4528287, First time in human (FTIH), Healthy participants, GlaxoSmithKline (GSK)
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK4528287Drug
GSK4528287 will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose 1 | Experimental | Participants will be administered Dose 1 of GSK4528287. Receives: Drug: GSK4528287 |
| Cohort 2: Dose 2 | Experimental | Participants will be administered Dose 2 of GSK4528287. Receives: Drug: GSK4528287 |
| Cohort 3: Dose 3 | Experimental | Participants will be administered Dose 3 of GSK4528287. Receives: Drug: GSK4528287 |
| Cohort 4: Dose 4 | Experimental | Participants will be administered Dose 4 of GSK4528287. Receives: Drug: GSK4528287 |
| Cohort 5: Dose 5 | Experimental | Participants will be administered Dose 5 of GSK4528287. Receives: Drug: GSK4528287 |
| Cohort 6: Dose 6 | Experimental | Participants will be administered Dose 6 of GSK4528287. Receives: Drug: GSK4528287 |
| Placebo | Placebo comparator | Participants will receive Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AE)
An AE is 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.
Measured: Up to Day 351 (End of follow up period)
Number of Participants with Serious Adverse Events (SAE)
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Measured: Up to Day 351 (End of follow up period)
Number of Participants with Clinically Significant Changes in Laboratory Values
Number of participants with clinically significant changes in laboratory values (hematology, chemistry, urinalysis, and virology) will be assessed.
Measured: Up to Day 351 (End of follow up period)
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs will be assessed.
Measured: Up to Day 351 (End of follow up period)
Number of Participants with Clinically Significant Changes in Telemetry
Number of participants with clinically significant changes in telemetry will be assessed.
Measured: On Day 1
Number of Participants with Clinically Significant Changes in 12 lead Electrocardiogram (ECG)
Number of participants with clinically significant changes in 12 lead ECG will be assessed.
Measured: Up to Day 351 (End of follow up period)
Secondary outcomes (7)
Area under concentration-time curve (AUC) of GSK4528287
Blood sample will be collected to evaluate plasma concentration of AUC of GSK4528287.
Measured: Up to Day 337
Maximum concentration (Cmax) of GSK4528287
Blood sample will be collected to evaluate plasma concentration of Cmax of GSK4528287.
Measured: Up to Day 337
Time to maximum concentration (Tmax) of GSK4528287
Blood sample will be collected to evaluate plasma concentration of Tmax of GSK4528287.
Measured: Up to Day 337
Apparent terminal phase half life (T-half) of GSK4528287
Blood sample will be collected to evaluate plasma concentration of T-half of GSK4528287.
Measured: Up to Day 337
Clearance (CL) of GSK4528287
Blood sample will be collected to evaluate plasma concentration of CL of GSK4528287.
Measured: Up to Day 337
Bioavailability of GSK4528287
Blood sample will be collected to evaluate plasma concentration of SC bioavailability of GSK4528287.
Measured: Up to Day 337
Number of Participants with Confirmed Positive and Negative anti-GSK4528287 Antibodies
Number of participants with confirmed positive and negative anti-GSK4528287 Antibodies will be assessed.
Measured: Up to Day 211
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start18 Nov 2024
- Primary completion23 Apr 2026
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- This is single centre, double-blind study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681181
- Sponsor's protocol ID
- 221603
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06681181
- Acronym / sponsor ID
- 221603
- Conditions
- Colitis, Ulcerative
- Keywords
- Inflammatory bowel disease, Crohns disease, Ulcerative colitis, GSK4528287, First time in human (FTIH), Healthy participants, GlaxoSmithKline (GSK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. The study will test single doses of GSK4528287 to check for side effects, measure blood levels, and understand how it works in the body. The study will start with a small dose, and the dose will be increased for each new group of participants."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- This is single centre, double-blind study.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose 1 | Experimental | Drug: GSK4528287Participants will be administered Dose 1 of GSK4528287. |
| Cohort 2: Dose 2 | Experimental | Drug: GSK4528287Participants will be administered Dose 2 of GSK4528287. |
| Cohort 3: Dose 3 | Experimental | Drug: GSK4528287Participants will be administered Dose 3 of GSK4528287. |
| Cohort 4: Dose 4 | Experimental | Drug: GSK4528287Participants will be administered Dose 4 of GSK4528287. |
| Cohort 5: Dose 5 | Experimental | Drug: GSK4528287Participants will be administered Dose 5 of GSK4528287. |
| Cohort 6: Dose 6 | Experimental | Drug: GSK4528287Participants will be administered Dose 6 of GSK4528287. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- White blood cell greater than or equal to (>=) lower limit of normal (LLN), including both lymphocyte counts >= LLN and neutrophil counts >= LLN, at both screening and pre-dose (Day-1) Note: in cases where the test is abnormal, the participant may have the test repeated once and if their second test is normal, they will be eligible. In the event a second test is also abnormal, the participant is not eligible
- Electrocardiogram (ECG) with no clinically significant abnormality at the discretion of the investigator/designee
- Participants with a confirmed positive vaccination status for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines as per local/site guidance
- SARS-CoV-2 screening test negative as per local guidance
Key exclusion criteria (38 listed)
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- Abnormal blood pressure as determined by the investigator
- Symptomatic herpes zoster within 3 months prior to screening
- Prior medical history of anaphylaxis or severe adverse reactions to vaccines
- Significant allergies to humanized monoclonal antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK4528287GSK4528287 will be administered. | Drug | Cohort 1: Dose 1, Cohort 2: Dose 2, Cohort 3: Dose 3, Cohort 4: Dose 4, Cohort 5: Dose 5, Cohort 6: Dose 6 |
| PlaceboPlacebo will be administered. | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events (AE)
Time frame: Up to Day 351 (End of follow up period)
An AE is 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.
Number of Participants with Serious Adverse Events (SAE)
Time frame: Up to Day 351 (End of follow up period)
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Number of Participants with Clinically Significant Changes in Laboratory Values
Time frame: Up to Day 351 (End of follow up period)
Number of participants with clinically significant changes in laboratory values (hematology, chemistry, urinalysis, and virology) will be assessed.
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 351 (End of follow up period)
Number of participants with clinically significant changes in vital signs will be assessed.
Number of Participants with Clinically Significant Changes in Telemetry
Time frame: On Day 1
Number of participants with clinically significant changes in telemetry will be assessed.
Number of Participants with Clinically Significant Changes in 12 lead Electrocardiogram (ECG)
Time frame: Up to Day 351 (End of follow up period)
Number of participants with clinically significant changes in 12 lead ECG will be assessed.
7 secondary outcomes
Area under concentration-time curve (AUC) of GSK4528287
Time frame: Up to Day 337
Maximum concentration (Cmax) of GSK4528287
Time frame: Up to Day 337
Time to maximum concentration (Tmax) of GSK4528287
Time frame: Up to Day 337
Apparent terminal phase half life (T-half) of GSK4528287
Time frame: Up to Day 337
Clearance (CL) of GSK4528287
Time frame: Up to Day 337
Bioavailability of GSK4528287
Time frame: Up to Day 337
Number of Participants with Confirmed Positive and Negative anti-GSK4528287 Antibodies
Time frame: Up to Day 211
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK4528287 in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site 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 11 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with Adverse Events (AE) (time frame: Up to Day 351 (End of follow up period)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.