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

Part of paid clinical trials in Princeton, New Jersey.

Sponsor
QuantX Biosciences, Inc.
Study ID
NCT07678463
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • QX-4533 — DRUG
    QX-4533 tablets
  • Placebo — DRUG
    QX-4533 matched-placebo tablets

Study Details

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.

Key Dates

Start date
Jul 2, 2026
Status verified
Jun 2026
Primary completion
Dec 25, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.
  • 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).
  • 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).

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]) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
103 Carnegie CenterPrincetonNew Jersey08540-

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103 Carnegie Center· Princeton, NJ

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