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

13 juli 2026 uppdaterad av: QuantX Biosciences, Inc.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part 1: Single Ascending Dose (SAD)
Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions.
QX-4533 tablets
QX-4533 matched-placebo tablets
Experimentell: 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.
QX-4533 tablets
QX-4533 matched-placebo tablets
Experimentell: 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).
QX-4533 tablets
Experimentell: 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).
QX-4533 tablets

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Gregory Bell, MD, Leader of Clinical Development Department

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 juli 2026

Primärt slutförande (Beräknad)

25 december 2026

Avslutad studie (Beräknad)

31 januari 2027

Studieregistreringsdatum

Först inskickad

25 juni 2026

Först inskickad som uppfyllde QC-kriterierna

25 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • QX4533-001

Plan för individuella deltagardata (IPD)

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NEJ

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produkt tillverkad i och exporterad från U.S.A.

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