Sikkerhed, farmakokinetik og fødevareeffekt af PS1 i sunde forsøgspersoner
2. juli 2026 opdateret af: Pharmasaga Co. Ltd.
Et fase I, dobbeltblindt, placebokontrolleret, randomiseret, enkelt- og multiple-stigende dosisstudie for at evaluere PS1's sikkerhed, tolerabilitet, farmakokinetik og fødevareeffekt hos raske forsøgspersoner
Dette er et fase I, dobbeltblindt, placebokontrolleret, randomiseret, enkelt- og multiple-stigende dosisstudie til evaluering af ny undersøgelsesintervention, PS1.
PS1 er en potentiel blodsukkerkontrolmedicin, som er udviklet af Pharmasaga Co. Ltd. planlagt til behandling af type II diabetes mellitus (T2DM).
Dette er et første-i-menneskeligt studie for at evaluere sikkerheden, tolerabiliteten, farmakokinetik (PK) og fødevareeffekten af PS1 hos raske forsøgspersoner.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette første-i-menneskelige fase I-studie består af en enkelt stigende dosis (SAD) portion, en fødevareeffekt (FE) portion og en multiple ascending-dose (MAD) portion, med det formål at evaluere sikkerhed, tolerabilitet, farmakokinetik, og fødevareeffekt af PS1 hos raske forsøgspersoner.
Et randomiseret, dobbeltblindet, placebokontrolleret studiedesign vil blive anvendt til SAD-delen med tre SAD-dosiskohorter - 100 mg (kohorte 1), 200 mg (kohorte 2) og 400 mg (kohorte 3). Et berettiget forsøgsperson i denne del vil modtage en enkelt dosis PS1- eller Placebo-tabletter i fodret tilstand på dag 1 og følges i 14 dage.
I FE-delen tildeles kun én årgang (kohorte 4). FE-kohorten (kohorte 4) vil bruge samme undersøgelsesdesign som SAD-kohorterne. Et berettiget forsøgsperson i denne del vil modtage en enkelt dosis på 100 mg PS1 eller placebo-tabletter i fastende tilstand på dag 1 og følges i 14 dage.
To kohorter er tildelt i MAD-delen: 50 mg/dag (kohorte 5) og 100 mg/dag (kohorte 6). Kun dosisniveauet af MAD lavere end den maksimalt tolererede dosis (MTD) af SAD-delen kan aktiveres (hvis 100 mg blev bestemt som MTD for SAD, kunne kun kohorte 5 aktiveres). En berettiget forsøgsperson vil modtage PS1- eller Placebo-tabletter én gang dagligt i fodret tilstand i 28 dage og blive fulgt i yderligere 14 dage.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
75
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Taipei, Taiwan
- Mingche Liu
-
-
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
20 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Begge køn i alderen 20 til 80 år, inklusive ved screening
- Åbent sundt forsøgsperson, som anses for at være generelt sundt baseret på sygehistorie, vitale tegn, laboratorietests, 12-aflednings EKG og fysisk undersøgelse, som vurderet af investigator
- Med HbA1c-værdi på < 6,5 % ved screening
- Fastende plasmaglukose < 110 mg/dL ved screening
- Body mass index (BMI) mellem 18,5 og 28,0 kg/m2
- Negativ test for hepatitis B overfladeantigen (HBsAg), Anti-HCV antistof eller human immundefektvirus (HIV) ved screening
- Er villig til at overholde forsøgets begrænsninger
- Kunne forstå og underskrive den informerede samtykkeerklæring
Ekskluderingskriterier:
- Historie om diabetes mellitus
- Under systemisk behandling af enhver receptpligtig medicin eller håndkøbsmedicin (OTC) inden for 7 dage før screening
- Modtog enhver vaccination inden for 14 dage før screening
- Kendt overfølsomhed over for nogen af komponenterne i PS1 tablet
- Anamnese med klinisk signifikant hæmatologisk, renal, endokrin, pulmonal, respiratorisk, gastrointestinal, kardiovaskulær, hepatisk, psykiatrisk, neurologisk, muskuloskeletal, immun eller allergisk sygdom (inklusive lægemiddelallergier, men eksklusive ubehandlede, asymptomatiske, sæsonbestemte allergier på tidspunktet for doseringen) inden for 3 måneder efter screening, der kan ændre biomarkørpanelet væsentligt, kræve modtagelse af systemisk medicin eller forstyrre fortolkningen af data, som vurderet af investigator
- Anamnese med kræft (malignitet) eller nogensinde har modtaget nogen form for kræftbehandling
- Almindelig ryger
- Indtaget mere end 3 glas alkoholholdige drikkevarer om dagen i de sidste 4 uger før screening
- Modtaget enhver undersøgelsesterapi fra et andet klinisk studie, udført større operationer eller taget glukosesænkende medicin inden for de sidste 12 uger før screening
- Modtaget systemiske steroider (inhalerede og intranasale steroider er tilladt) eller anden immunsuppressiv medicin inden for 4 uger før screening
- Har nogensinde modtaget celleterapi eller organtransplantation
- Andre forhold, der ikke er egnede til at deltage i denne undersøgelse, vurderet af investigator
- Eventuelle forhold, der forbyder gennemførelsen af undersøgelsesprocedurer på grund af de lokale lovgivningsmæssige begrænsninger
- Kvinde i den fødedygtige alder, som:
er ammende; eller har et positivt graviditetstestresultat fra at have underskrevet informeret samtykke til afslutningen af undersøgelsen; eller nægter at anvende mindst én form for prævention (se afsnit 5.3) fra underskrivelse af informeret samtykke til afslutningen af undersøgelsen.
- Mandlig forsøgsperson med en kvindelig ægtefælle/partner, der er i den fødedygtige alder, nægter at vedtage mindst én form for prævention (se afsnit 5.3) fra at underskrive informeret samtykke til afslutningen af undersøgelsen.
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: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: SAD portion - Cohort 1 (25mg)
An eligible healthy subject will receive a single dose of 25 mg of PS1 or Placebo tablet in a fed condition on Day 1 and be followed for 7 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: SAD portion - Cohort 2 (50mg)
An eligible healthy subject will receive a single dose of 50 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: SAD portion - Cohort 3 (75mg)
An eligible healthy subject will receive a single dose of 75 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: FE portion - Cohort 4 (50mg)
An eligible healthy subject will receive a single dose of 50 mg PS1 or Placebo tablets in a fasted condition on Day 1 and be followed for 7 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: SAD portion - Cohort A (25mg)
An eligible T2DM subject will receive 25 mg PS1 tablet once daily in a fed condition for 1 day and be followed for additional 14 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: SAD portion - Cohort B (50mg)
An eligible T2DM subject will receive 50 mg PS1 tablets once daily in a fed condition for 1 day and be followed for additional 14 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: MAD portion - Cohort 7 (25mg)
An eligible subject will receive 25 mg PS1 or Placebo tablet once daily in a fed condition for 28±1 days and be followed for additional 7 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
|
Eksperimentel: MAD portion - Cohort 8 (50mg)
An eligible subject will receive 50 mg PS1 or Placebo tablets once daily in a fed condition for 28±1 days and be followed for additional 7 days.
|
PS1 vil blive leveret som en 120 mg tablet med 25 mg aktiv farmaceutisk ingrediens.
Andre navne:
Placebo vil blive leveret som en 120 mg tablet.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of dose-limiting toxicity (DLT) during the DLT observation period and the maximum tolerated dose (MTD) of PS1
Tidsramme: DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1
|
Dose escalation will be terminated based on the following criteria: - Among the six subjects who received PS1 in a cohort, more than one subject experienced DLT(s). MTD will basically be declared as the highest dose level at which ≤1/6 of PS1-treated subjects in a cohort experienced DLT(s). DLT is defined as
that occurs in the DLT observation period and is causally related (possibly, probably, or definitely related) to the test article judged by the investigator. |
DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
All adverse events (AEs) will be assessed for severity by the investigator based on NCI-CTCAE v5.0
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in vital signs (Systolic Blood Pressure & Diastolic Blood Pressure) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Systolic Blood Pressure & Diastolic Blood Pressure)(Unit: mmHg)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Hematology (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) (Unit: g/dL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in acute kidney injury (AKI)-NGAL markers at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Urine samples will be collected for analyzing acute kidney injury (AKI) markers, NGAL.
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in 12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
PR interval, QRS interval, and QT interval will be recorded.
[Unit: msec]
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Abnormalities in Physical examination
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal Physical examination findings, including general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
AUC_Area under the serum concentration-time profile
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
Cmax_The peak post-dose concentration
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
Tmax_Time at which Cmax is observed
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
T1/2_Terminal phase elimination half-life
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
MRT_Mean Residence Time
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
CL/F_Apparent Clearance
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
Volume of distribution
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Pharmacokinetics (PK) of PS1
Tidsramme: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
Rac_Accumulation ratio
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
|
Potential efficacy (For Cohort 7 and 8 only)
Tidsramme: MAD in T2DM subjects: Approximately 7 weeks
|
Changes from baseline of fasting plasma glucose (FPG) at each post-treatment visit; Changes from baseline of C-peptide at each post-treatment visit; Changes from baseline of hemoglobin A1c (HbA1c) at Visit 10 and Visit 11.
|
MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes from baseline of postprandial plasma glucose (PPG), at each post-treatment visit in T2DM patients
Tidsramme: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Postprandial plasma glucose (PPG) data.
|
SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes from baseline of postprandial serum insulin (PSI) at each post-treatment visit in T2DM patients
Tidsramme: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Postprandial serum insulin (PSI) data.
|
SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes from baseline of fasting serum insulin (FSI) at each post-treatment visit in T2DM patients
Tidsramme: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Fasting serum insulin (FSI) data.
|
SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in acute kidney injury (AKI)-KIM-1 markers at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Urine samples will be collected for analyzing acute kidney injury (AKI) markers, KIM-1.
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Biochemistry at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Biochemistry physiological parameter tests results
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Urinalysis at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Urinalysis physiological parameter tests results
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in vital signs (Pulse rate) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Pulse rate) (Unit: beats/min)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in vital signs (Respiratory Rate) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Respiratory Rate) (Unit: breaths/min)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in vital signs (Temperature) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Temperature) (Unit: Celsius)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Hematology (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) (Unit: %)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Hematology (RBC) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (RBC) (Unit: 10^6/uL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Hematology (platelet and WBC) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (platelet and WBC) (Unit: 10^3/uL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Hematology (mean corpuscular volume, MCV) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular volume, MCV) (Unit: fL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in Laboratory examinations - Hematology (mean corpuscular hemoglobin, MCH) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular hemoglobin, MCH) (Unit: pg)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
|
Changes in 12-lead electrocardiogram (EKG) (Ventricular rate) at each post-treatment measurement from baseline
Tidsramme: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Ventricular rate will be recorded.
[Unit: beats/min]
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory Endpoints (For MAD only)
Tidsramme: MAD in T2DM subjects: Approximately 7 weeks
|
Changes from baseline of serum PDIA4
|
MAD in T2DM subjects: Approximately 7 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mingche Liu, MD., PhD, Taipei Medical University 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)
22. december 2023
Primær færdiggørelse (Faktiske)
27. april 2026
Studieafslutning (Faktiske)
5. juni 2026
Datoer for studieregistrering
Først indsendt
29. november 2021
Først indsendt, der opfyldte QC-kriterier
3. januar 2022
Først opslået (Faktiske)
4. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PS1-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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