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- Klinische proef NCT03745625
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
A Single-center, Open-label, Randomized, Double-crossover, Propofol-controlled, Two-stage Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of IV Maintenance Dose After An Initial Dose and IV Single Loade Dose Plus Maintenance Dose of HSK3486 Emulsion fo Injection in Healthy Subjects
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Chengdu, China
- West China Hospital,Sichuan University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Healthy males or females with full capacity for civil conduct, aged ≥ 18 and ≤ 49 years old;
- Body weight > 45 kg, and body mass index (BMI) ≥ 19 and ≤26 kg/m2;
- Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 °C; respiration rate between 12-20 breaths per minute; SpO2 when inhaling > 95%;
- Normal physical examinations, laboratory examinations (routine blood test, blood biochemistry and routine urinalysis), and 12-Lead ECG, or abnormal but without clinical significance; no potential difficult airway (modified Mallampati score I-III);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; No history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with trial protocol.
Exclusion Criteria:
- Known sensitivity to propofol, excipients in propofol medium-/long-chain triglyceride emulsion injection, excipients in HSK3486 emulsion injection (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
- History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during screening;
- Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year;
- Serious infection, trauma or major surgery within 4 weeks before screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks before screening, including GI diseases or infections (such as respiratory or CNS infections);
- In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 3 days prior to screening;
- In receipt of prescription drugs, Chinese herbal medicines, over-the-counter drugs or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to enrollment; unless the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial;
- History of cardiovascular diseases such as: postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥ 450 ms (Fridericia's correction formula);
- Impaired respiratory function, history of obstructive pulmonary disease, history of asthma, sleep apnea syndromes; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute upper respiratory tract infection, and with obvious symptoms such as fever, wheezing, nasal congestion and cough within 1 week prior to baseline;
- History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration;
Laboratory results that meet any of the following during screening/enrollment:
- Positive test for either HBsAg, HCV, HIV, or syphilis;
Abnormal hepatic or renal function confirmed after re-examination;
- ALT or AST > 1×ULN;
- Creatinine > 1×ULN;
- TBIL > 1.5×ULN;
- History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive blood alcohol concentration during screening;
- Blood donation or blood loss ≥ 200 mL within 30 days before the trial; plasma donation or plasma exchange within 7 days before the trial;
- Subjects who continue to smoke, drink alcohol, or consume any food or beverages containing xanthine or caffeine, to participate in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to enrollment; subjects who are unable to fast for 6 hours prior to dose administration;
- Subjects expected to have surgery or hospitalization during the trial;
- Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: HSK3486
First-stage: 1mg/kg/h, 0.4mg/kg/h; Second-stage:Single loading dose: 0.2mg/kg, maintenance dose: 0.35mg/kg/h,
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First-stage:after an initial dose of 1mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h. Second-stage: a single loading dose of 0.2 mg/kg given over 1 minute, then a continuous infusion of maintenance dose 0.35 mg/kg/h for a total infusion time of 12h. |
Actieve vergelijker: Propofol
First-stage: 5mg/kg/h, 2mg/kg/h; Second-stage:Single load ing dose: 1mg/kg, maintenance dose: 1.75mg/kg/h
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First-stage: after an initial dose of 5mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h. Second-stage: loading dose of 1mg/kg given over 1 minute, then a continuous infusion of maintenance dose 1.75 mg/kg/h for a total infusion time of 12h. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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bloeddruk (systolische, diastolische en gemiddelde arteriële druk)
Tijdsspanne: vanaf de screening tot 3 dagen na de dosis
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veiligheid eindpunten
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vanaf de screening tot 3 dagen na de dosis
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heart rate
Tijdsspanne: from the screening to 3 days post-dose
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safety endpoits
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from the screening to 3 days post-dose
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respiratory rate
Tijdsspanne: from the screening to 3 days post-dose
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safety endpoits
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from the screening to 3 days post-dose
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blood oxygen saturation
Tijdsspanne: from the screening to 3 days post-dose
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safety endpoits
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from the screening to 3 days post-dose
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Number of patients with adverse events
Tijdsspanne: from the baseline to 3 days post-dose
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safety endpoits
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from the baseline to 3 days post-dose
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Totale opruiming
Tijdsspanne: -30 minuten voor toediening tot 24 uur na toediening op dag 1
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-30 minuten voor toediening tot 24 uur na toediening op dag 1
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Distributievolume
Tijdsspanne: -30 minuten voor toediening tot 24 uur na toediening op dag 1
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-30 minuten voor toediening tot 24 uur na toediening op dag 1
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Richmond Agitation Sedation Scale( scores:+4~-5)
Tijdsspanne: -30 minutes before administration until the subject is completely awakened post administration on day 1
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Change from baseline in Richmond Agitation Sedation Scale(RASS) score
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-30 minutes before administration until the subject is completely awakened post administration on day 1
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Bispectral index
Tijdsspanne: -30 minutes before administration until the subject is completely awakened post administration on day 1
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-30 minutes before administration until the subject is completely awakened post administration on day 1
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Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Tijdsspanne: -30 minutes before administration until the subject is completely awakened post administration on day 1
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-30 minutes before administration until the subject is completely awakened post administration on day 1
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Terminal elimination half life
Tijdsspanne: -30 minutes before administration until 24 hours post administration on day 1
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-30 minutes before administration until 24 hours post administration on day 1
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plasma concentration at the end of infusion
Tijdsspanne: -30 minutes before administration until 24 hours post administration on day 1
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-30 minutes before administration until 24 hours post administration on day 1
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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area under curve from time 0 to the last measurable blood sampling time (AUC0-last)
Tijdsspanne: -30 minutes before administration until 24 hours post administration on day 1
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-30 minutes before administration until 24 hours post administration on day 1
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area under curve from time 0 to infinite time (AUC0-inf)
Tijdsspanne: -30 minutes before administration until 24 hours post administration on day 1
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-30 minutes before administration until 24 hours post administration on day 1
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Peak concentration
Tijdsspanne: -30 minutes before administration until 24 hours post administration on day 1
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-30 minutes before administration until 24 hours post administration on day 1
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time to peak observed (Tmax)
Tijdsspanne: -30 minutes before administration until 24 hours post administration on day 1
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-30 minutes before administration until 24 hours post administration on day 1
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HSK3486-102
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op HSK3486
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Sichuan Haisco Pharmaceutical Group Co., LtdThe First Hospital of Jilin UniversityVoltooidGezonde Oudere OnderwerpenChina
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Sichuan Haisco Pharmaceutical Group Co., LtdVoltooid
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Sichuan Haisco Pharmaceutical Group Co., LtdThe First Affiliated Hospital of Zhengzhou UniversityVoltooidChronische nierfunctiestoornisChina
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Sichuan Haisco Pharmaceutical Group Co., LtdVoltooidAnesthesie | SedatieChina
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Sichuan Haisco Pharmaceutical Group Co., LtdIngetrokken
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Sichuan Haisco Pharmaceutical Group Co., LtdVoltooid
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Sichuan Haisco Pharmaceutical Group Co., LtdThe First Hospital of Jilin UniversityVoltooidLeverfunctiestoornisChina
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Sichuan Haisco Pharmaceutical Group Co., LtdVoltooidInductie en onderhoud van algemene anesthesieChina
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University of Medicine and Dentistry of New JerseyIngetrokkenVulvaire kankerVerenigde Staten
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Sichuan Haisco Pharmaceutical Group Co., LtdVoltooid