Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: qiaofeng qu
- Numero di telefono: +86 021-34782827
- Email: qfqu@immunophage.com.cn
Luoghi di studio
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310013
- Zhejiang Hospital
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Contatto:
- Wanggang Zhang, Master
- Numero di telefono: +86 13738194591
- Email: zhangwgnian@126.com
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male and female Chinese participants aged 18-50 years inclusive.
- 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.
- 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.
- Female participants are non-pregnant and non-lactating.
- 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.
- 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.
- Voluntarily sign written informed consent form.
Exclusion Criteria:
- History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
- ECG: QTcF >450 ms (male) / >470 ms (female).
- Recurrent headache/migraine, recurrent nausea/vomiting.
- Blood donation ≥400 mL within 3 months before screening.
- History of orthostatic hypotension, dysphagia.
- Gastrointestinal disorders affecting drug absorption.
- Cannot comply with unified diet requirements, lactose intolerance.
- Major surgery within 3 months before screening or planned surgery during study.
- Known hypersensitivity to study drug or placebo excipients.
- Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
- Excessive alcohol / tobacco / caffeine intake defined per protocol.
- 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.
- Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
- Vaccines or biological agents within 4 months pre-screening or planned during study.
- Participation in another interventional clinical trial within 3 months before screening.
- Difficult venous access, history of needle-phobia.
- Acute disease within 14 days prior to screening.
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
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Sperimentale: Part-A-100 mg Cohort
Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition |
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Sperimentale: Part-A-300 mg Cohort
Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition |
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Sperimentale: 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 |
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Sperimentale: 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 |
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Sperimentale: 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 |
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Sperimentale: 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 |
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Sperimentale: 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 |
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Sperimentale: 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 |
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Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
Lasso di tempo: Up to 96 hours post-dose
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Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
Lasso di tempo: Up to 96 hours post-dose
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Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
Lasso di tempo: Up to 96 hours post-dose
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Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A
Lasso di tempo: Up to 96 hours post-dose
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Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A
Lasso di tempo: Up to 96 hours post-dose
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Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
Lasso di tempo: Up to 96 hours post-dose
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Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
Lasso di tempo: Day 1 to Day 13
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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
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Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
Lasso di tempo: Day 1 to Day 13
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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
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Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B
Lasso di tempo: Day 1 to Day 13
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Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
Lasso di tempo: Day 1 to Day 13
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Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
Lasso di tempo: Day 1 to Day 13
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Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
Lasso di tempo: Day 1 to Day 13
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Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Safety indicators:adverse event
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Part A: Safety indicators:adverse event
Lasso di tempo: Up to 8-day follow-up
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Up to 8-day follow-up
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Part B: Safety indicators:adverse event
Lasso di tempo: Up to Day16 follow-up
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Up to Day16 follow-up
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Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts
Lasso di tempo: Day30 for 100/200 mg QD groups
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Day30 for 100/200 mg QD groups
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Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.
Lasso di tempo: Day90 for 300 mg QD group
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Day90 for 300 mg QD group
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Part C: Changes from baseline in body weight (kg) across all scheduled visits
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Changes from baseline BMI across all scheduled visits
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Changes from baseline waist circumference across all scheduled visits
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Cmax following first and last dosing.
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Tmax following first and last dosing.
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: AUC₀-τ following the first dose and last dose
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Accumulation index
Lasso di tempo: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- IPG1094-HV-C002
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