A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: QX-4533; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shu Wang, MD; Phone Number: +86 18036618586; Email: shu.wang@quantxbio.com
• Study Contact Backup: Name: Yiting Chi, MD; Phone Number: +86 13482779422; Email: Yiting.Chi@quantxbio.com

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia
      • Recruiting
      • Nucleus Network Brisbane (Q-pharm)
      • Contact: Anthony Johnson; Phone Number: 07 3707 2787; Email: a.johnson@nucleusnetwork.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Ascending Dose (SAD); Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions.	Drug: QX-4533; QX-4533 tablets; Drug: Placebo; QX-4533 matched-placebo tablets
Experimental: Part 2: Multiple Ascending Dose (MAD); Participants will receive multiple oral doses of QX-4533 or placebo, once daily for 14 days under fasting conditions.	Drug: QX-4533; QX-4533 tablets; Drug: Placebo; QX-4533 matched-placebo tablets
Experimental: Part 3: Food Effect - Sequence 1: AB; 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).	Drug: QX-4533; QX-4533 tablets
Experimental: Part 3: Food Effect - Sequence 2: BA; 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).	Drug: QX-4533; QX-4533 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	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	From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Time of the Maximum Measured Concentration (Tmax)	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)	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)	Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Volume of Distribution at Steady State (Vz/F)	Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Clearance (CL/F)	Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Terminal Elimination Half-Life (t½el)	Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings	From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])

Collaborators and Investigators

• Sponsor: QuantX Biosciences, Inc.
• Investigators: Study Chair: Gregory Bell, MD, Leader of Clinical Development Department

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QX4533-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No