NCT07678463 A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants
| NCT ID | NCT07678463 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | QuantX Biosciences US Inc. |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2026-12-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2026-07-10 with a primary completion date of 2026-12-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.
Eligibility Criteria
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.
Contact & Investigator
Gregory Bell, MD
STUDY CHAIR
Leader of Clinical Development Department
Frequently Asked Questions
Who can join the NCT07678463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07678463 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07678463 currently recruiting?
Yes, NCT07678463 is actively recruiting participants. Contact the research team at shu.wang@quantxbio.com for enrollment information.
Where is the NCT07678463 trial being conducted?
This trial is being conducted at Brisbane, Australia.
Who is sponsoring the NCT07678463 clinical trial?
NCT07678463 is sponsored by QuantX Biosciences US Inc.. The principal investigator is Gregory Bell, MD at Leader of Clinical Development Department. The trial plans to enroll 90 participants.