- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07678463
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Shu Wang, MD
- Telefonnummer: +86 18036618586
- E-mail: shu.wang@quantxbio.com
Undersøgelse Kontakt Backup
- Navn: Yiting Chi, MD
- Telefonnummer: +86 13482779422
- E-mail: Yiting.Chi@quantxbio.com
Studiesteder
-
-
Queensland
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Brisbane, Queensland, Australien
- Rekruttering
- Nucleus Network Brisbane (Q-pharm)
-
Kontakt:
- Anthony Johnson
- Telefonnummer: 07 3707 2787
- E-mail: a.johnson@nucleusnetwork.com.au
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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).
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QX-4533 tablets
|
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Eksperimentel: 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).
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QX-4533 tablets
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
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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
Tidsramme: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
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From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Time of the Maximum Measured Concentration (Tmax)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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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)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
|
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Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
|
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Apparent Volume of Distribution at Steady State (Vz/F)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
|
|
Apparent Clearance (CL/F)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Terminal Elimination Half-Life (t½el)
Tidsramme: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
|
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Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings
Tidsramme: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
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From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Gregory Bell, MD, Leader of Clinical Development Department
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- QX4533-001
Plan for individuelle deltagerdata (IPD)
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