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Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

9 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Studietyp

Interventionell

Inskrivning (Beräknad)

72

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310013
        • Zhejiang Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Experimentell: Part-A-100 mg Cohort

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

Experimentell: Part-A-300 mg Cohort

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

Experimentell: 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

Experimentell: 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

Experimentell: 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

Experimentell: 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

Experimentell: 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

Experimentell: 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

Experimentell: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Tidsram
Part A: Safety indicators:adverse event
Tidsram: Up to 8-day follow-up
Up to 8-day follow-up
Part B: Safety indicators:adverse event
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

25 november 2026

Primärt slutförande (Beräknad)

25 juni 2027

Avslutad studie (Beräknad)

25 augusti 2027

Studieregistreringsdatum

Först inskickad

28 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

9 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

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