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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

13. februar 2022 opdateret af: Ark Biosciences Inc.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.

The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.

A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Jersey
      • Secaucus, New Jersey, Forenede Stater, 07094
        • Frontage

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Capable of giving written informed consent and complying with study procedures;
  2. Between the ages of 18 and 55 years, inclusive;
  3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
  4. Female subjects must have a negative pregnancy test result at screening;
  5. Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
  6. Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.

Exclusion Criteria:

  1. Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
  2. Poor venous access;
  3. Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
  4. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
  5. Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
  6. Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: ziresovir

The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.

Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:

  • If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
  • If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
  • If administered 180 mL as the study drug dose, follow with approximately 60 mL water.
Medicin: Ziresovir

Planned treatments are:

  • Cohort 1: 300 mg of ziresovir
  • Cohort 2: up to 600 mg of ziresovir
  • Cohort 3: up to 900 mg of ziresovir
Andre navne:
  • AK0529
Placebo komparator: placebo

The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.

Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:

  • If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
  • If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
  • If administered 180 mL as the study drug dose, follow with approximately 60 mL water.
Andet: Placebo

Planned treatments are:

  • Cohort 1: 300 mg of placebo
  • Cohort 2: up to 600 mg of placebo
  • Cohort 3: up to 900 mg of placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
numbers of all AEs
Tidsramme: through study completion, an average of 22 days
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
through study completion, an average of 22 days
percentages of all AEs
Tidsramme: through study completion, an average of 22 days
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
through study completion, an average of 22 days
change from baseline in systolic and diastolic blood pressure
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
blood pressure in millimeter of mercury
screen/day -1/day 1/day 2/day 3/day4
change from baseline in pulse rate
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
pulse rate in times per minute
screen/day -1/day 1/day 2/day 3/day4
change from baseline in respiratory rate
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
respiratory rate in times per minute
screen/day -1/day 1/day 2/day 3/day4
change from baseline in oral temperature
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
oral temperature in degree
screen/day -1/day 1/day 2/day 3/day4
change from baseline in Prothrombin time/International Normalized Ratio
Tidsramme: screen/day -1/day 2/day4
INR is calculated from the PT and allows for worldwide standardization of results.
screen/day -1/day 2/day4
change from baseline in Thrombin time
Tidsramme: screen/day -1/day 2/day4
Thrombin time in seconds
screen/day -1/day 2/day4
change from baseline in activated Partial Thromboplastin time
Tidsramme: screen/day -1/day 2/day4
activated Partial Thromboplastin time in seconds
screen/day -1/day 2/day4
change from baseline in Hemoglobin (Hgb) count
Tidsramme: screen/day -1/day 2/day4
Hemoglobin (Hgb) in gram per liter
screen/day -1/day 2/day4
change from baseline in Hematocrit (Hct)
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Platelet count
Tidsramme: screen/day -1/day 2/day4
Platelet count per liter
screen/day -1/day 2/day4
change from baseline in Red blood cell (RBC) count
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in White blood cell (WBC) count with differential
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Specific gravity from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in pH from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Protein from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Glucose from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Ketones from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Bilirubin from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Blood from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Nitrites from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Leukocytes from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Urobilinogen from urinalysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
Incidence of abnormal Microscopic urine analysis
Tidsramme: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in heart rate from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in QRS intervals from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in appearance of U-waves from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
Incidence of abnormal physical findings
Tidsramme: screen/day -1/day2/day3/day4
full physical examination will be conducted at screening and an abbreviated physical exam will be conducted on Day -1 and Day 2. A symptom-directed physical exam will be conducted on Day 3 and Day 4.
screen/day -1/day2/day3/day4

Sekundære resultatmål

Resultatmål
Tidsramme
To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
Tidsramme: 0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ark Biosciences Inc.

Efterforskere

  • Studieleder: Jimmy Gu, Ark Biosciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. marts 2021

Primær færdiggørelse (Faktiske)

14. juni 2021

Studieafslutning (Faktiske)

22. juli 2021

Datoer for studieregistrering

Først indsendt

1. februar 2021

Først indsendt, der opfyldte QC-kriterier

4. marts 2021

Først opslået (Faktiske)

9. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AK0529-3001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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