- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Shu Wang, MD
- Telefonnummer: +86 18036618586
- E-post: shu.wang@quantxbio.com
Studer Kontakt Backup
- Navn: Yiting Chi, MD
- Telefonnummer: +86 13482779422
- E-post: Yiting.Chi@quantxbio.com
Studiesteder
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Queensland
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Brisbane, Queensland, Australia
- Rekruttering
- Nucleus Network Brisbane (Q-pharm)
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Ta kontakt med:
- Anthony Johnson
- Telefonnummer: 07 3707 2787
- E-post: a.johnson@nucleusnetwork.com.au
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Part 1: Single Ascending Dose (SAD)
Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions.
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QX-4533 tablets
QX-4533 matched-placebo tablets
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Eksperimentell: 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.
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QX-4533 tablets
QX-4533 matched-placebo tablets
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Eksperimentell: 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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Eksperimentell: 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
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Hva måler studien?
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])
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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])
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
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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)
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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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Gregory Bell, MD, Leader of Clinical Development Department
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- QX4533-001
Plan for individuelle deltakerdata (IPD)
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