Unknown
PHASE1
INTERVENTIONAL
NCT05112159
Study of IPG1094 in Healthy Participants
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of single dose orally administered IPG1094 in healthy adult participants.
Interventions
Name:
IPG1094
Type:
DRUG
Description:
The IPG1094 drug product is supplied as oral tablet dosage form, containing two strengths: 50 mg and 100 mg, respectively, which contain IPG1094.
Name:
placebo
Type:
DRUG
Description:
Matching placebo tablets to IPG1094 50mg and 100mg
Primary Outcomes
Measure:
Occurrence of all adverse events
TimeFrame:
Up to 8 days
Description:
Evaluation of adverse events
Measure:
RBC
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
white blood cell count (WBC)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
platelet count (PLT)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
haemoglobin (HGB)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
mean corpuscular hemoglobin
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
mean corpuscular hemoglobin concentration
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
Hematocrit
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
mean corpuscular volume (MCV)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
absolute differential leukocyte count (eosinophils)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
absolute differential leukocyte count (monocytes)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
absolute differential leukocyte count (lymphocytes)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
absolute differential leukocyte count (basophils)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
absolute differential leukocyte count (neutrophils)
TimeFrame:
Up to 8 days
Description:
Evaluation of Hematology
Measure:
Temperature (°C )
TimeFrame:
Up to 8 days
Description:
Evaluation of Vital Signs
Measure:
Respiration rate
TimeFrame:
Up to 8 days
Description:
Evaluation of Vital Signs
Measure:
Pulse rate
TimeFrame:
Up to 8 days
Description:
Evaluation of Vital Signs
Measure:
Blood pressure (both systolic and diastolic)
TimeFrame:
Up to 8 days
Description:
Evaluation of Vital Signs
Measure:
Standard 12-lead ECG - heart rate
TimeFrame:
Up to 8 days
Description:
Evaluation of Electrocardiograms
Measure:
Standard 12-lead ECG - QTcF
TimeFrame:
Up to 8 days
Description:
Evaluation of Electrocardiograms
Measure:
Standard 12-lead ECG - PR
TimeFrame:
Up to 8 days
Description:
Evaluation of Electrocardiograms
Measure:
Standard 12-lead ECG - QRS
TimeFrame:
Up to 8 days
Description:
Evaluation of Electrocardiograms
Measure:
Standard 12-lead ECG - QT
TimeFrame:
Up to 8 days
Description:
Evaluation of Electrocardiograms
Measure:
Alanine aminotransferase (ALT)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
albumin (ALB)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
alkaline phosphatase (ALP)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
aspartate aminotransferase (AST)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
total bilirubin (TBil)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
Urea
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
calcium (Ca)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
chloride (Cl)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
cholesterol (CHO)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
creatinine (Cr)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
creatine kinase (CK)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
glucose (Glu)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
lactate dehydrogenase (LDH)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
phosphate (P)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
potassium (K)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
sodium (Na)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
total protein (TP)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Chemistry
Measure:
Prothrombin time (PT)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Coagulation
Measure:
activated partial thromboplastin time (APTT)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Coagulation
Measure:
fibrinogen
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Coagulation
Measure:
international normalized ratio (INR)
TimeFrame:
Up to 8 days
Description:
Evaluation of Serum Coagulation
Measure:
pH
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
Bilirubin (U-BIL)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
glucose (GLU)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
urine erythrocytes (U-RBC)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
ketones (U-KET)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
Urinary leukocyte (U-LEU)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
nitrites (U-NIT)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
protein (U-PRO)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
specific gravity (U-SG)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Measure:
urobilinogen (URO)
TimeFrame:
Up to 8 days
Description:
Evaluation of Urinalysis
Trial Information
NCT ID
NCT05112159
Status
Unknown
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Nanjing Immunophage Biotech Co., Ltd
Last Updated
December 15, 2025