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

7. april 2021 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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 ).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

    • Shanghai
      • Shanghai, Shanghai, Kina, 200030
        • Rekruttering
        • Shanghai Mental Health Center
        • Kontakt:
        • Kontakt:
          • Li Yan, Research Doctor
          • Telefonnummer: 021-34773107
          • E-mail: lhlh_5@163.com
        • Ledende efterforsker:
          • Hua Fang Li, MD
        • Underforsker:
          • Li Yan, Research Doctor

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 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andre navne:
  • placebo
Eksperimentel: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andre navne:
  • placebo
Eksperimentel: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andre navne:
  • placebo
Eksperimentel: 10mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andre navne:
  • placebo
Eksperimentel: 18mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andre navne:
  • placebo
Eksperimentel: 24mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Andre navne:
  • placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of AEs
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cmax
Tidsramme: 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
Tidsramme: 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-∞
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Hua Fang li, MD, Shanghai Mental Health Center

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)

2. marts 2021

Primær færdiggørelse (Forventet)

1. august 2021

Studieafslutning (Forventet)

1. august 2021

Datoer for studieregistrering

Først indsendt

6. april 2021

Først indsendt, der opfyldte QC-kriterier

7. april 2021

Først opslået (Faktiske)

9. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2021

Sidst verificeret

1. april 2021

Mere information

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