- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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New Jersey
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Secaucus, New Jersey, Forente stater, 07094
- Frontage
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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:
Andre navn:
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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:
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Planned treatments are:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
numbers of all AEs
Tidsramme: through study completion, an average of 22 days
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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
Tidsramme: through study completion, an average of 22 days
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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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change from baseline in systolic and diastolic blood pressure
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
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blood pressure in millimeter of mercury
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in pulse rate
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
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pulse 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 respiratory rate
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
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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
Tidsramme: screen/day -1/day 1/day 2/day 3/day4
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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
Tidsramme: screen/day -1/day 2/day4
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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
Tidsramme: screen/day -1/day 2/day4
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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
Tidsramme: screen/day -1/day 2/day4
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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
Tidsramme: screen/day -1/day 2/day4
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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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in White blood cell (WBC) count with differential
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Specific gravity from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in pH from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Protein from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Glucose from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Ketones from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Bilirubin from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Blood from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Nitrites from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Leukocytes from urinalysis
Tidsramme: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Urobilinogen from urinalysis
Tidsramme: 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
Tidsramme: 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
Tidsramme: screen/day -1/day1/day2/day4
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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
Tidsramme: 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 QRS intervals from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
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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 treatment-emergent T-wave morphology from resting 12-lead ECGs
Tidsramme: screen/day -1/day1/day2/day4
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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
Tidsramme: screen/day -1/day1/day2/day4
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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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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
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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
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Jimmy Gu, Ark Biosciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AK0529-3001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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