- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03570346
Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects
29. september 2018 opdateret af: Tianjin Hemay Bio-Tech Co., Ltd
A Randomised, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Hemay005 in Healthy Subjects
Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis.
A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30mg, 60mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort.
This study includes an 28-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hongyun Wang, Doctor
- Telefonnummer: 010-69156576
- E-mail: wanghy@pumch.cn
Studiesteder
-
-
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Beijing, Kina
- Rekruttering
- Peking Union Medical College Hospital
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Kontakt:
- Hongyun Wang, Doctor
- Telefonnummer: 010-69156576
- E-mail: wanghy@pumch.cn
-
-
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 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects aged 18 to 60 years, male and female volunteers;
- Male Bodyweight(BW)≥ 50kg, female Bodyweight(BW)≥ 45kg, Body mass index (BMI) in 18-28 (including upper and lower limit of the range);
- All male subjects must agree and commit to the use of a reliable contraceptive regimen(including vasoligation, abstinence, using a condom) for the duration of the study(from screening until 6 months after the last dose), Female participants with a negative pregnancy test (serum) at both the screening visit and at Day-1, Female subjects and female partners of male subjects must agree and commit to the use of a reliable contraceptive regimen ( oral contraceptive medications or non-oral contraceptive medications) for the duration of the study(from screening until 6 months after the last dose);
- Ability to understand and be willing to sign a written informed consent before study entry;
- Subjects would have good communication with the investigator and could comply with protocol.
Exclusion Criteria:
- A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders;
- Have a known history of hypersensitivity to any medicine or food, or allergy to the test article or any of the excipient of the test article;
- Have a gastrointestinal, hepatic or renal condition that may influence drug absorption or metabolism;
- A history of chronic infection (ie, tuberculosis);
- A medical history of any clinically significant medical disease or surgery within 4 weeks of the screening;
- Clinically significant laboratory abnormal results at screening or prior to the first dose of study drug;
- Clinically significant abnormal 12-lead ECG or vital signs ( systolic pressure <90 mmHg or >140 mmHg, diastolic pressure <50 mmHg or >90 mmHg; radial pulse rate <50 bpm or >100 bpm);
- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
- Recent history of frequent alcohol consumption, defined by average intake of greater than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol content, or 150 mL wine), Participants who are unable to abstain from smoking during the study or quitting smoking for less than 3 months;
- Positive urine screen for drug and cigarettes, positive breath test for alcohol;
- Subjects who use soft drugs (ie marijuana )within 3 months of the screening and entire study duration or hard drugs (ie cocaine, phencyclidine ) within 1 year of the screening and entire study duration;
- Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit;
- Participants who eat special food (Including grapefruit and/or Xanthine diet) for 14 days prior to dosing or any caffeine containing food or drinks, i.e. chocolate for 48 hours prior to dosing or drinking alcohol for 24 hours prior to dosing and not will stop to intake above food and drinks;
- Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of planned study drug administration and entire study duration (e.g. inducers: barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoid and omeprazole; inhibitors - Selective Serotonin Reuptake Inhibitors(SSRI )antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);
- Participant who received any medicine within 14 days of the initial dose of study drug;
- Have received other clinical trials treatment within 3 months prior to study;
- Participants who have donated of blood (>400 mL) within 4 weeks of the study, or plan to donate of blood during of the study and 4 weeks after the study;
- Subjects cannot complete the study due to other reasons or by the investigator's judgment;
- Pregnancy or lactating females
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Hemay005
6 subjects in each cohort(15mg, 30mg, 60mg) will receive Hemay005
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Subjects will be randomized into 3 dose groups orally twice daily.
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Placebo komparator: Placebo
2 subjects in each cohort(15mg, 30mg, 60mg) will receive placebo
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Subjects will be randomized into 3 dose groups orally twice daily.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of adverse events and serious adverse events.
Tidsramme: Day1 up to Day20±3
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Day1 up to Day20±3
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cmax
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
|
Maximum observed plasma concentration
|
pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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area under the curve from time zero to the last quantifiable concentration
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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area under the curve from time zero extrapolated to infinity
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Area under the plasma concentration-time curve from time zero extrapolated to infinity
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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t1/2
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Terminal elimination half-life
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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clearance CL/F
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Apparent total plasma clearance
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Vz/F
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Apparent total volume of distribution
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Hongyun Wang, Doctor, Peking Union Medical College Hospital
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)
10. juli 2018
Primær færdiggørelse (Forventet)
20. oktober 2018
Studieafslutning (Forventet)
1. december 2018
Datoer for studieregistrering
Først indsendt
17. juni 2018
Først indsendt, der opfyldte QC-kriterier
17. juni 2018
Først opslået (Faktiske)
26. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HM005PS1S03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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Kliniske forsøg med Psoriasis
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ProgenaBiomeRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis ansigt | Psoriasis negl | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaForenede Stater
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AmgenAfsluttetPsoriasis-Psoriasis | Plaque-type psoriasisForenede Stater
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Innovaderm Research Inc.AfsluttetPsoriasis i hovedbunden | Pustulær Palmo-plantar Psoriasis | Ikke-pustulær Palmo-plantar Psoriasis | Albue Psoriasis | Psoriasis i underbenetCanada
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UCB Biopharma S.P.R.L.AfsluttetModerat til svær psoriasis | Generaliseret pustulær psoriasis og erytrodermisk psoriasisJapan
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TakedaRekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
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PfizerAfsluttetPsoriasis Vulgaris | Pustuløs psoriasis | Psoriasis Arthropathica | Erytrodermisk psoriasisJapan
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Janssen Pharmaceutical K.K.RekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
-
Eli Lilly and CompanyAfsluttetGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
Kliniske forsøg med Hemay005
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Ganzhou Hemay Pharmaceutical Co., LtdHemay Pharmaceutical PTY. LTD.Afsluttet
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Tianjin Hemay Pharmaceutical Co., LtdAfsluttet
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Ganzhou Hemay Pharmaceutical Co., LtdIkke rekrutterer endnu
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Ganzhou Hemay Pharmaceutical Co., LtdAfsluttet
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Ganzhou Hemay Pharmaceutical Co., LtdIkke rekrutterer endnu
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Tianjin Hemay Pharmaceutical Co., LtdAfsluttet
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Solvay PharmaceuticalsAfsluttetGastrectomiDanmark, Finland, Norge, Sverige
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Tianjin Hemay Bio-Tech Co., LtdAfsluttet
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Tianjin Hemay Pharmaceutical Co., LtdAfsluttet