- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04788017
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
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New Jersey
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Secaucus, New Jersey, Förenta staterna, 07094
- Frontage
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Capable of giving written informed consent and complying with study procedures;
- Between the ages of 18 and 55 years, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Female subjects must have a negative pregnancy test result at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
- Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.
Exclusion Criteria:
- 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;
- Poor venous access;
- 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;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
- 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;
- 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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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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:
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Planned treatments are:
Andra namn:
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Placebo-jämförare: 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:
|
Planned treatments are:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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numbers of all AEs
Tidsram: through study completion, an average of 22 days
|
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
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through study completion, an average of 22 days
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percentages of all AEs
Tidsram: 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
Tidsram: 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
Tidsram: screen/day -1/day 1/day 2/day 3/day4
|
pulse rate in times per minute
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screen/day -1/day 1/day 2/day 3/day4
|
|
change from baseline in respiratory rate
Tidsram: screen/day -1/day 1/day 2/day 3/day4
|
respiratory rate in times per minute
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screen/day -1/day 1/day 2/day 3/day4
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|
change from baseline in oral temperature
Tidsram: screen/day -1/day 1/day 2/day 3/day4
|
oral temperature in degree
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in Prothrombin time/International Normalized Ratio
Tidsram: screen/day -1/day 2/day4
|
INR is calculated from the PT and allows for worldwide standardization of results.
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screen/day -1/day 2/day4
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change from baseline in Thrombin time
Tidsram: screen/day -1/day 2/day4
|
Thrombin time in seconds
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screen/day -1/day 2/day4
|
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change from baseline in activated Partial Thromboplastin time
Tidsram: screen/day -1/day 2/day4
|
activated Partial Thromboplastin time in seconds
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screen/day -1/day 2/day4
|
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change from baseline in Hemoglobin (Hgb) count
Tidsram: screen/day -1/day 2/day4
|
Hemoglobin (Hgb) in gram per liter
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screen/day -1/day 2/day4
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change from baseline in Hematocrit (Hct)
Tidsram: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Platelet count
Tidsram: screen/day -1/day 2/day4
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Platelet count per liter
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screen/day -1/day 2/day4
|
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change from baseline in Red blood cell (RBC) count
Tidsram: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
|
|
|
change from baseline in White blood cell (WBC) count with differential
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
|
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change from baseline in Specific gravity from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
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change from baseline in pH from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
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change from baseline in Protein from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
|
|
change from baseline in Glucose from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
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change from baseline in Ketones from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
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change from baseline in Bilirubin from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
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change from baseline in Blood from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
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change from baseline in Nitrites from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
|
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change from baseline in Leukocytes from urinalysis
Tidsram: screen/day -1/day 2/day4
|
screen/day -1/day 2/day4
|
|
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change from baseline in Urobilinogen from urinalysis
Tidsram: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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Incidence of abnormal Microscopic urine analysis
Tidsram: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
Tidsram: screen/day -1/day1/day2/day4
|
ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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|
change from baseline in heart rate from resting 12-lead ECGs
Tidsram: 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
Tidsram: screen/day -1/day1/day2/day4
|
ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
|
|
change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
Tidsram: screen/day -1/day1/day2/day4
|
ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
|
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change from baseline in appearance of U-waves from resting 12-lead ECGs
Tidsram: screen/day -1/day1/day2/day4
|
ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
|
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Incidence of abnormal physical findings
Tidsram: screen/day -1/day2/day3/day4
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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.
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screen/day -1/day2/day3/day4
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
Tidsram: 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
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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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Jimmy Gu, Ark Biosciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AK0529-3001
Plan för individuella deltagardata (IPD)
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