New drug IRL757 passes first safety check in healthy humans
NCT ID NCT06493045
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety of a new drug, IRL757, in 82 healthy adults aged 18-55. Participants received either single or multiple doses of the drug or a placebo. The study focused on side effects and how the drug moves through the body, not on treating any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IRL757
- What this could lead to
- If safe, this could pave the way for future studies to see if IRL757 might treat a disease.
- What could go wrong
- This is a very early, first-in-human trial in healthy people, not patients. It only checks safety, not whether the drug works for any condition.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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82 people
The number who actually took part.
- Started
-
May 2024
- Finished
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Feb 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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: * Willing and able to give written informed consent for participation in the trial. * Healthy male or female subject aged 18-55 years inclusive. * Weight of at least 50 kg and no more than 110 kg at screening. * Willing to use highly effective methods of contraception Exclusion Criteria: * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial. * History or present clinically significant psychiatric diagnosis, at discretion of the Investigator. * Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent). * History of seizures, including febrile seizure in childhood. * Any clinically significant illness, medical/surgical procedure or trauma within four (4) weeks of the first administration of IMP. * Any planned major surgery within the duration of the trial. * Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV). * After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges: Systolic blood pressure \> 140 mm Hg, Diastolic blood pressure \> 90 mm Hg, Heart rate \< 40 or \> 85 beats per minute. * Prolonged QTcF (\> 450 ms for male subjects or \> 470 ms for female subjects), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator. * History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL757. * Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within two (2) weeks prior to the first administration of IMP, except occasional intake of paracetamol (maximum 2 000 mg/day; and not exceeding 3 000 mg/week), at the discretion of the Investigator. * Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within three (3) months of the first administration of IMP in this trial. Subjects consented and screened but not dosed in previous phase I studies are not excluded. * Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three (3) times per week is allowed before screening visit. * History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator. * Positive screen for drugs of abuse at screening or on admission to the unit or positive screen for alcohol at screening or on admission to the unit prior to administration of the IMP. * Use of anabolic steroids. * Current excessive use of caffeine, as judged by the Investigator. * Plasma donation within one (1) month of screening or any blood donation/blood loss \> 450 mL during the three (3) months prior to screening. * Investigator considers the subject unlikely to comply with trial procedures, restrictions and requirements.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CTC Clinical Trial Consultants AB, Uppsala University Hospital
Uppsala, Sweden
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