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A Phase I Study to Evaluate the Food Effect on Ecnoglutide Tablet

11. november 2026 opdateret af: Hangzhou Sciwind Biosciences Co., Ltd.

A Randomized, Open-label, Multiple-dose, Multicenter Phase I Study to Evaluate the Food Effect on the Pharmacokinetics of Ecnoglutide Tablets in Chinese Adult Participants

The aim of the study is to evaluate food effect on pharmacokinetics of oral ecnoglutide tablets in Chinese participants

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

There are two parts in this study. Part I will assess the effect of high-fat meal, while eligible participants will be randomized and allocated to either cohort F1(fasting) or F2(with meal) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days. Part II will assess the effect of different dosing conditions, while eligible participants will be randomized and allocated to either cohort T1(no intake after 30min of dosing) or T2(no intake after 60min of dosing) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

72

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Zhejiang Provincial People's Hospital
        • Kontakt:

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 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Body mass index (BMI): 19.0 kg/m² ≤ BMI < 30.0 kg/m², with body weight ≥ 55 kg (male) or ≥ 50 kg (female);
  2. Participants of childbearing potential agree to have no plans for pregnancy during the entire study period and within 6 months after the last dose: female participants must be non-pregnant and non-lactating, with no plans to donate ova, and male participants must have no plans to donate sperm; all participants voluntarily use effective contraception, with female participants avoiding pregnancy and male participants avoiding causing pregnancy in their partners;

Exclusion Criteria:

  1. History of severe drug allergy (especially known or suspected allergy to any component of Ecnoglutide Tablets, regardless of the severity of previous allergic reactions), or severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis, etc.), or discretion by the investigator to have a severe allergic condition (e.g., allergy to two or more drugs/foods, or repeated allergic reactions requiring medical intervention);
  2. Diagnosis of overweight or obesity of endocrine origin, such as Cushing's syndrome;
  3. Diagnosis of diabetes mellitus of any type (excluding gestational diabetes mellitus);
  4. History of acute or chronic pancreatitis, pancreatic injury, symptomatic biliary disease, or other high-risk factors that may lead to pancreatitis;
  5. Diagnosis of other endocrine diseases of significant clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging showing C-TIRADS ≥ 4A), thyroid cancer, or a personal or family history of multiple endocrine neoplasia type 2 (MEN2);
  6. Occurrence of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, severe irritable bowel syndrome, celiac disease, recurrent dyspepsia, or clinically abnormal gastric emptying (e.g., pyloric obstruction), within 6 months prior to screening; or presence of gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation at screening/before the first dose;
  7. Occurrence of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration, etc.), within 6 months prior to screening;
  8. Diagnosis of malignant tumor within 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., as discreted by the investigator to be clinically insignificant;
  9. History of depression, or other severe psychiatric illness, or suicidal ideation or suicidal behavior;
  10. Within 3 months prior to screening, participation in and use of any investigational drug, vaccine, special medical food, or invasive device clinical trial, or planned participation in other clinical trials during the study period;

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: F1

Day 1 to Day 14: Fast overnight for at least 10 hours before each dose, and take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration.

oral, once daily for 7 days

oral, once daily for 7 days

Eksperimentel: F2

Day 1 to Day 13: take breakfast within 30min before each dose, and then take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration.

Day 14: take breakfast with high fat and high calorie

oral, once daily for 7 days

oral, once daily for 7 days

Eksperimentel: T1

Day 1 to Day 14: fast after 30min of dosing

oral, once daily for 7 days

oral, once daily for 7 days

Eksperimentel: T2

Day 1 to Day 14: fast after 60min of dosing

oral, once daily for 7 days

oral, once daily for 7 days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum concentration
Tidsramme: From Day1 to Day42

Cmax of ecnoglutide

From Day1 to Day42
Minimum concentration
Tidsramme: From Day1 to Day42

Cmin of ecnoglutide

From Day1 to Day42
Area under the curve from time 0 to infinity
Tidsramme: From Day1 to Day42

AUC0-∞of ecnoglutide

From Day1 to Day42
Area under the curve from time 0 to 24h
Tidsramme: From Day1 to Day42

AUC0-24h of ecnoglutide

From Day1 to Day42
Area under the curve from time 0 to last quantifiable time point
Tidsramme: From Day1 to Day42

AUC0-t of ecnoglutide

From Day1 to Day42
Time to reach maximum concentration
Tidsramme: From Day1 to Day42

Tmax of ecnoglutide

From Day1 to Day42

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of adverse events
Tidsramme: From Day1 to Day42
From Day1 to Day42
Anti-drug antibody
Tidsramme: From Day1 to Day42

ADA of ecnoglutide

From Day1 to Day42

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Yiwen Zhang, Zhejiang Provincial People's 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 (Anslået)

3. november 2026

Primær færdiggørelse (Anslået)

15. april 2027

Studieafslutning (Anslået)

15. april 2027

Datoer for studieregistrering

Først indsendt

4. november 2026

Først indsendt, der opfyldte QC-kriterier

11. november 2026

Først opslået (Faktiske)

13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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