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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QX-4533 | Drug | QX-4533 tablets |
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| Measure | Description | 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]) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu Wang, MD | Contact | +86 18036618586 | shu.wang@quantxbio.com | |
| Yiting Chi, MD | Contact | +86 13482779422 | Yiting.Chi@quantxbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Bell, MD | Leader of Clinical Development Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Brisbane | Queensland | Australia |
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Part 3 FE is Cross over study model.
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FE study will be open label.
| Placebo | Drug | QX-4533 matched-placebo tablets |
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| 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]) |