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A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects

7 april 2021 bijgewerkt door: Jiangsu Nhwa Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects

The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects.

Studie Overzicht

Gedetailleerde beschrijving

Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).

This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).

Studietype

Ingrijpend

Inschrijving (Verwacht)

60

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Hua Fang li, MD
  • Telefoonnummer: 021-34773107
  • E-mail: lhlh_5@163.com

Studie Contact Back-up

  • Naam: Li Yan, Research Doctor
  • Telefoonnummer: 021-34773107
  • E-mail: lhlh_5@163.com

Studie Locaties

    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Werving
        • Shanghai Mental Health Center
        • Contact:
        • Contact:
          • Li Yan, Research Doctor
          • Telefoonnummer: 021-34773107
          • E-mail: lhlh_5@163.com
        • Hoofdonderzoeker:
          • Hua Fang Li, MD
        • Onderonderzoeker:
          • Li Yan, Research Doctor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Male/female subjects are 18<age ≤45 years of age when signing the informed consent.
  2. Male Subjects with body weight of ≥50.0kg ,and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination.
  3. After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
  4. Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study.

Exclusion Criteria:

  1. The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
  2. There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
  3. Subjects with past history of allergy to drugs or allergic disease.
  4. Subjects with currently or past history of mental disorders and brain functional disorders.
  5. According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
  6. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
  7. Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
  8. Average amount of daily smoking>5 cigarettes at screening 3 months prior.
  9. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
  10. Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
  11. Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
  12. Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
  13. Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
  14. Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit.
  15. Subjects who participated in any clinical trial within 3 months before medication.
  16. Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
  17. Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
  18. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
  19. Subjects who directly related to this clinical trial.
  20. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andere namen:
  • placebo
Experimenteel: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andere namen:
  • placebo
Experimenteel: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andere namen:
  • placebo
Experimenteel: 10mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andere namen:
  • placebo
Experimenteel: 18mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andere namen:
  • placebo
Experimenteel: 24mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andere namen:
  • placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of AEs
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Incidence of Adverse Events
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cmax
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Maximum (peak) observed drug serum concentration
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-t
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-∞
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
%AUCex
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Extrapolation percentage of AUC0-∞
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Tmax
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Time of occurrence of Cmax
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
T1/2
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Vd
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Apparent volume of distribution
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
CL
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Clearance
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
λz
Tijdsspanne: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Elimination rate constant
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Hua Fang li, MD, Shanghai Mental Health Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 maart 2021

Primaire voltooiing (Verwacht)

1 augustus 2021

Studie voltooiing (Verwacht)

1 augustus 2021

Studieregistratiedata

Eerst ingediend

6 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

7 april 2021

Eerst geplaatst (Werkelijk)

9 april 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 april 2021

Laatste update ingediend die voldeed aan QC-criteria

7 april 2021

Laatst geverifieerd

1 april 2021

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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