Phase 1 Study of QX-4533 in Healthy Volunteers and Patients With Moderate-to-Severe Atopic Dermatitis

Sponsor
QuantX Biosciences, Inc.
Study ID
NCT07800104
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 65 Years
Healthy Volunteers
Accepted

Interventions

  • QX4533 — DRUG
    QX-4533, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers
  • QX4533 Placebo — DRUG
    QX-4533 placebo, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers

Study Details

The goal of this clinical trial is to evaluate the safety and tolerability of QX-453, an investigational treatment, in healthy Chinese volunteers and patients with moderate-to-severe atopic dermatitis. The study will assess how the drug is absorbed and processed by the body, and check for any side effects. Participants will receive single or repeated oral doses of QX-453 under close medical supervision, with regular safety and clinical assessments throughout the trial.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 7, 2026
Status verified
Aug 2026
Primary completion
Apr 14, 2027
Completion
May 19, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QX4533
    oral tablets administered once daily
  • Placebo Comparator: QX4533 Placebo
    oral tablets administered once daily

Primary Outcome Measure

Incidence of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 43 [Part 2]) ]

Central Contacts

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