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NCT06681181

NCT06681181
Active, Not Recruiting Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are generally in good health, based on a full medical check-up including blood tests and heart monitoring
  • Your white blood cell counts (including two specific types: lymphocytes and neutrophils) are within the normal range at both your screening appointment and the day before your dose (if one result is slightly off, you may be retested once)
  • Your heart tracing (ECG) shows no concerning abnormalities, as judged by the study doctor
  • You have been fully vaccinated against COVID-19 as required by local guidelines
  • You test negative for COVID-19 at screening
  • If dosing happens during flu season (October to April), you must have received an approved flu vaccine at least 30 days before your dose (if you haven't already had one that season)
  • You weigh at least 50 kg (about 110 lbs) and your body mass index (BMI) is between 18 and 32
  • You are male or a female who cannot become pregnant
  • If you are male, you agree to avoid donating sperm and to use contraception or remain abstinent for 48 weeks after your single dose
  • If you are female, you are confirmed to be unable to become pregnant
  • You are able and willing to give your informed consent to take part

Who may not be able to join:

  • You have a significant history of, or currently have, serious heart, lung, liver, kidney, digestive, hormone, blood, or nervous system conditions
  • You have abnormal blood pressure, as determined by the study doctor
  • You have had a shingles outbreak with symptoms within the 3 months before screening
  • You have previously had a severe allergic reaction (anaphylaxis) or serious reaction to a vaccine
  • You have a significant allergy to humanised monoclonal antibody medicines (a type of drug) (confirm with trial site)
  • You have a history of severe drug allergies, intolerance to certain skin treatments, or severe skin reactions to medications (confirm with trial site)
  • You have a condition that weakens your immune system or an autoimmune disease (where the body attacks itself)
  • You have a history of getting infections repeatedly
  • You have been treated for a significant infection in the 3 months before your first dose, such as a serious skin infection or a lung infection like pneumonia
  • You have any history of long-term infections including tuberculosis (TB), hepatitis B, hepatitis C, or HIV
  • You currently have any infection (including a cold or urinary infection) that has not fully cleared up at least 4 weeks before dosing
  • You have a known allergy or sensitivity to any of the study medications or their ingredients
  • You have any history of cancer, including skin cancer
  • You previously had a moderate or severe case of COVID-19 that required hospital admission or oxygen treatment
  • You have received a biologic medicine (such as a monoclonal antibody drug) within the past 3 months or 5 half-lives of that drug, whichever is longer
  • You have taken antibiotics or antiviral medicines within 30 days before dosing
  • You have received a live vaccine within 1 month before screening, or plan to receive one during the study
  • You have taken any over-the-counter or prescription medicines, including herbal remedies, within 7 days before dosing
  • You have taken part in another clinical trial and received an experimental medicine within 30 days (or longer, depending on that medicine) before this study's first dose
  • You have taken part in 4 or more other clinical trials involving new experimental medicines in the past 12 months
  • You are currently enrolled in, or have previously taken part in, this specific trial
  • You have donated blood or taken part in a study involving blood donation of more than 500 mL in the past 56 days
  • You test positive for tuberculosis (TB) at screening
  • You test positive for HIV at screening
  • You test positive for drugs or alcohol (including cannabis) at screening or on Day 1
  • You are a current smoker, or have regularly used tobacco or nicotine products (such as patches or vapes) within the past 6 months
  • You test positive for COVID-19 or have symptoms suggesting COVID-19 at screening or before your dose
  • The study doctor considers you to be at high risk of TB infection (for example, you live in an area where TB is common, or you have had close contact with someone confirmed

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 1
Sponsor
GlaxoSmithKline
Registry
clinicaltrials_gov
Start date
18 November 2024
Est. completion
23 April 2026

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Number of Participants with Adverse Events (AE); Number of Participants with Serious Adverse Events (SAE); Number of Participants with Clinically Significant Changes in Laboratory Values; Number of Participants with Clinically Significant Changes in Vital Signs; Number of Participants with Clinically Significant Changes in Telemetry; Number of Participants with Clinically Significant Changes in 12 lead Electrocardiogram (ECG)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov