HealthyPhase 1NCT07678463
A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants
A Phase 1 study testing QX-4533 in people with Healthy, run by QuantX Biosciences, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- QX-4533
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jul 2026to 31 Jan 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Brisbane (Q-pharm)
Brisbane, Queensland
Anthony Johnson, 07 3707 2787, a.johnson@nucleusnetwork.com.au
About this study
Official title: A Three-part, Phase 1, Single and Multiple Ascending Dose Escalation and Food Effect Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of QX-4533
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.
Read the detailed description
This study will consist of 3 parts: Part 1: A randomized, double-blind, placebo-controlled single ascending dose (SAD) evaluation, including an open-label crossover food effect (FE) assessment in 1 cohort.
Part 2: A 14-day randomized, double-blind, placebo-controlled multiple ascending dose (MAD) evaluation.
Part 3: An open-label, 2-period crossover FE assessment.
- Conditions
- Healthy
- Being tested
- QX-4533, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QX-4533Drug
QX-4533 tablets
PlaceboDrug
QX-4533 matched-placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions. Receives: Drug: QX-4533; Drug: Placebo |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Participants will receive multiple oral doses of QX-4533 or placebo, once daily for 14 days under fasting conditions. Receives: Drug: QX-4533; Drug: Placebo |
| Part 3: Food Effect - Sequence 1: AB | Experimental | Participants will receive single oral dose of QX-4533 on Day 1 of Period 1 under fasted condition (A) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fed (high fat meal) condition (B). Receives: Drug: QX-4533 |
| Part 3: Food Effect - Sequence 2: BA | Experimental | Participants will receive a single oral dose of QX-4533 on Day 1 of Period 1 under fed (high fat meal) condition (B) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fasted condition (A). Receives: Drug: QX-4533 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Measured: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Time of the Maximum Measured Concentration (Tmax)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Volume of Distribution at Steady State (Vz/F)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Clearance (CL/F)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Terminal Elimination Half-Life (t½el)
Measured: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings
Measured: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start10 Jul 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 3 FE is Cross over study model.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QuantX Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Bell, MD, Study chair, Leader of Clinical Development Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678463
- Sponsor's protocol ID
- QX4533-001
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-part, Phase 1, Single and Multiple Ascending Dose Escalation and Food Effect Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of QX-4533
- ClinicalTrials.gov ID
- NCT07678463
- Acronym / sponsor ID
- QX4533-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- QuantX Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Jul 2026 (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.
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.
Detailed description
This study will consist of 3 parts: Part 1: A randomized, double-blind, placebo-controlled single ascending dose (SAD) evaluation, including an open-label crossover food effect (FE) assessment in 1 cohort.
Part 2: A 14-day randomized, double-blind, placebo-controlled multiple ascending dose (MAD) evaluation.
Part 3: An open-label, 2-period crossover FE assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Part 3 FE is Cross over study model.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: QX-4533, Drug: PlaceboParticipants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions. |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Drug: QX-4533, Drug: PlaceboParticipants will receive multiple oral doses of QX-4533 or placebo, once daily for 14 days under fasting conditions. |
| Part 3: Food Effect - Sequence 1: AB | Experimental | Drug: QX-4533Participants will receive single oral dose of QX-4533 on Day 1 of Period 1 under fasted condition (A) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fed (high fat meal) condition (B). |
| Part 3: Food Effect - Sequence 2: BA | Experimental | Drug: QX-4533Participants will receive a single oral dose of QX-4533 on Day 1 of Period 1 under fed (high fat meal) condition (B) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fasted condition (A). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| QX-4533QX-4533 tablets | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD), Part 3: Food Effect - Sequence 1: AB, Part 3: Food Effect - Sequence 2: BA |
| PlaceboQX-4533 matched-placebo tablets | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD) |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Time of the Maximum Measured Concentration (Tmax)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Volume of Distribution at Steady State (Vz/F)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Clearance (CL/F)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Terminal Elimination Half-Life (t½el)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
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 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Gregory Bell, MD study chair
Leader of Clinical Development Department
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 QX-4533 in people with Healthy, run by QuantX Biosciences, Inc. at 1 site in Australia.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 Australia. 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. 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?
Contact Shu Wang, MD (+86 18036618586, shu.wang@quantxbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])). The study lists 2 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 15 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.