First human trial of QX-4533 begins safety testing
NCT ID NCT07678463
First seen Jul 01, 2026 · Last updated Jul 16, 2026 · Updated 5 times
Summary
This phase 1 trial tests the safety and tolerability of a new drug called QX-4533 in 90 healthy adults aged 18 to 55. Participants receive either single or multiple doses of the drug or a placebo, and the study also looks at how food affects the drug's levels in the body. The goal is to gather early safety data and understand how the drug behaves, which is a necessary step before testing it in people with a specific disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QX-4533
- What this could lead to
- If safe, this could pave the way for future studies testing QX-4533 as a potential treatment for an undisclosed condition.
- What could go wrong
- This is an early-phase trial in healthy volunteers, so it cannot show whether the drug works for any disease. Side effects or lack of tolerability may stop further development.
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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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- 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
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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: * Male or female between 18 and 55 years of age (inclusive) at screening. * Understands the study procedures and is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Willing and able to comply with this protocol and be available for the entire duration of the study. * In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at screening and Day -1. * Has body mass index of 18 to 32 kilograms per meter square (kg/m\^2) inclusive. Exclusion Criteria: * History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease according to the Investigator. * History of any Gastrointestinal (GI) procedures (e.g., bariatric surgery) that could impair gastrointestinal absorption. * History of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant. * Clinically significant abnormalities on pre-study clinical examination or laboratory safety tests. Laboratory safety assessments (e.g., serum chemistry, hematology, coagulation) will be performed at screening and on Day -1 (if screening is prior to Day -1) to confirm eligibility. * Treatment with a live (attenuated) vaccine within 8 weeks before the screening visit. * Positive hepatitis B surface antigen, human immunodeficiency virus antibody, or hepatitis C antibody at the screening visit. * Use of any prescription within 14 days prior to study treatment administration or use of any over-the-counter medications including food supplements and herbal medications (e.g., St. John's wort), except for contraceptive medications and as needed (pro re nata) paracetamol (not exceeding 2 g/day) within 7 days prior to study treatment administration. * Participant has participated in another clinical study within the last 4 weeks or within 5 half-lives of the prior study drug, whichever is longer. * Participants that currently use (including "recreational use") any illicit drugs or have a history of drug abuse in the last 2 years.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Nucleus Network Brisbane (Q-pharm)
RECRUITINGBrisbane, Queensland, Australia
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