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Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

9 novembre 2026 mis à jour par: Nanjing Immunophage Biotech Co., Ltd

A Phase Ⅰ Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Weight-Loss Effect of IPG1094 Tablets in Chinese Healthy Adults and Obese Adult Participants

This is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary weight-loss effect of IPG1094 tablets. The study includes three parts: Part A is single ascending dose in healthy volunteers; Part B is multiple ascending dose in healthy volunteers; Part C is multiple-dose exploration in obese adult participants. Subjects will be randomly assigned to receive IPG1094 or matching placebo. Safety, blood drug concentration and weight-related indicators will be followed up.

Aperçu de l'étude

Statut

Pas encore de recrutement

Type d'étude

Interventionnel

Inscription (Estimé)

72

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310013
        • Zhejiang Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 50 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Male and female Chinese participants aged 18-50 years inclusive.
  2. Part A/B (healthy adults): Physical examination, vital signs, 12-lead ECG, chest X-ray, laboratory tests are normal or abnormalities considered not clinically significant by investigator; male body weight ≥50.0 kg, female ≥45.0 kg; BMI 19.0-26.0 kg/m².
  3. Part C (obese adults): BMI 28.0-35.0 kg/m²; body weight stable within 3 months prior to screening (weight change ≤5%). No concomitant diseases interfering with safety, PK or weight evaluation.
  4. Female participants are non-pregnant and non-lactating.
  5. All participants (male and female) agree to use effective contraception from informed consent through 6 months after last study drug administration; no plan for pregnancy, sperm / oocyte donation.
  6. For Part C: Able to complete hospitalization for first 10 days, outpatient visits, home drug administration and study diary; refrain from additional weight-loss medications, bariatric surgery or intensive weight-loss programs.
  7. Voluntarily sign written informed consent form.

Exclusion Criteria:

  1. History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
  2. ECG: QTcF >450 ms (male) / >470 ms (female).
  3. Recurrent headache/migraine, recurrent nausea/vomiting.
  4. Blood donation ≥400 mL within 3 months before screening.
  5. History of orthostatic hypotension, dysphagia.
  6. Gastrointestinal disorders affecting drug absorption.
  7. Cannot comply with unified diet requirements, lactose intolerance.
  8. Major surgery within 3 months before screening or planned surgery during study.
  9. Known hypersensitivity to study drug or placebo excipients.
  10. Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
  11. Excessive alcohol / tobacco / caffeine intake defined per protocol.
  12. Use of metformin or other biguanides within 3 months before screening; systemic glucocorticoids within 1 month before screening; CYP-modifying drugs within 30 days before screening; prescription/OTC/herbal products within 14 days before screening.
  13. Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
  14. Vaccines or biological agents within 4 months pre-screening or planned during study.
  15. Participation in another interventional clinical trial within 3 months before screening.
  16. Difficult venous access, history of needle-phobia.
  17. Acute disease within 14 days prior to screening.
  18. Other conditions judged inappropriate for enrollment by investigator. Additional Exclusion for Part C (obese participants): Fasting glucose ≥11.0 mmol/L or HbA1c ≥8.0%; secondary obesity, eating disorders, clinically significant cardiovascular disease, moderate-severe obstructive sleep apnea, active liver disease, significant renal impairment.

Repeated BP: SBP ≥160 mmHg or DBP ≥100 mmHg; ALT/AST >2×ULN; total bilirubin >1.5×ULN; eGFR <60 mL/min/1.73 m².

Weight-loss drugs, intensive weight-loss program within 3-month pre-screening; prior or planned bariatric surgery.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Expérimental: Part-A-100 mg Cohort

Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

Expérimental: Part-A-300 mg Cohort

Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

Expérimental: Part-B1-50 mg QD Cohort

Drug: IPG1094 Tablet 50 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

Expérimental: Part-B2-100 mg QD Cohort

Drug: IPG1094 Tablet 100 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

Expérimental: Part-B3-200 mg QD Cohort

Drug: IPG1094 Tablet 200 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

Expérimental: Part-B4-100 mg BID Optional Cohort(optional, depends on safety/PK data)

Drug: IPG1094 Tablet 100 mg BID post-meal;Drug: Matching Placebo Tablet BID post-meal

Expérimental: Part-C1-100 mg QD Obese Cohort

Drug: IPG1094 Tablet 100 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

Expérimental: Part-C2-200 mg QD Obese Cohort

Drug: IPG1094 Tablet 200 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

Expérimental: Part-C3-300 mg QD Obese Cohort

Drug: IPG1094 Tablet 300 mg QD post-meal for 90 days;Drug: Matching Placebo Tablet QD post-meal for 90 days

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
Délai: Up to 96 hours post-dose

Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
Délai: Up to 96 hours post-dose

Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
Délai: Up to 96 hours post-dose

Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A
Délai: Up to 96 hours post-dose

Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A
Délai: Up to 96 hours post-dose

Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
Délai: Up to 96 hours post-dose

Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
Délai: Day 1 to Day 13

Multiple-dose steady-state maximum observed plasma concentration (Css,max) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
Délai: Day 1 to Day 13

Multiple-dose time to steady-state maximum plasma concentration (Tss,max) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B
Délai: Day 1 to Day 13

Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
Délai: Day 1 to Day 13

Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
Délai: Day 1 to Day 13

Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
Délai: Day 1 to Day 13

Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Safety indicators:adverse event
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

Mesures de résultats secondaires

Mesure des résultats
Délai
Part A: Safety indicators:adverse event
Délai: Up to 8-day follow-up
Up to 8-day follow-up
Part B: Safety indicators:adverse event
Délai: Up to Day16 follow-up
Up to Day16 follow-up
Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts
Délai: Day30 for 100/200 mg QD groups
Day30 for 100/200 mg QD groups
Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.
Délai: Day90 for 300 mg QD group
Day90 for 300 mg QD group
Part C: Changes from baseline in body weight (kg) across all scheduled visits
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Changes from baseline BMI across all scheduled visits
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Changes from baseline waist circumference across all scheduled visits
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Cmax following first and last dosing.
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Tmax following first and last dosing.
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: AUC₀-τ following the first dose and last dose
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Accumulation index
Délai: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

25 novembre 2026

Achèvement primaire (Estimé)

25 juin 2027

Achèvement de l'étude (Estimé)

25 août 2027

Dates d'inscription aux études

Première soumission

28 octobre 2026

Première soumission répondant aux critères de contrôle qualité

9 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

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Étudie un produit d'appareil réglementé par la FDA américaine

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