Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered IPG1094 in Healthy Adult Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: IPG1094 100 mg SAD; Drug: IPG1094 300 mg SAD; Drug: IPG1094 600 mg SAD; Drug: IPG1094 900 mg SAD; Drug: IPG1094 1200 mg SAD; Drug: IPG1094 600 mg MAD QD; Drug: IPG1094 200 mg MAD BID; Drug: IPG1094 300 mg MAD BID; Drug: IPG1094 300 mg Fasted-Fed; Drug: IPG1094 300 mg Fed-Fasted

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Scientia Clinical Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants must meet all of the following criteria to be included in the study:

Demography

1. Healthy adult male or female participants between 18 and 50 years of age (inclusive).

2. Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18~32 kg/m2 (inclusive).

   Health status

3. In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests.

   Vital signs (measured after resting for 5 minutes seated position) within normal range, or outside the normal range and not considered clinically significant by the Investigator.

   Standard 12-lead ECG parameters (recorded after resting for 5 minutes in supine position) in the following ranges; corrected QT interval(QTc) (Fridericia algorithm recommended) ≤ 450 ms for males and 470 ms for females, and normal ECG tracing, or abnormal ECG tracing not considered clinically relevant by the Investigator.

   Laboratory parameters demonstrating no clinically significant abnormalities, as determined by the Investigator. A total bilirubin outside the normal range may be acceptable if total bilirubin does not exceed 1.5 × upper limit of normal(ULN) conjugated bilirubin (with the exception of a participant with documented Gilbert syndrome).

4. A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).

5. Female participants must not be pregnant or breastfeeding and must use an effective contraception method (as described in Section 4.5.4), with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal.

   A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the Investigational Medicinal Product (IMP). The participant must be excluded from the study if the serum pregnancy test is positive.

   A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle stimulating hormone（FSH） measurement (> 40 IU/L or milli-International unit（mIU）/mL).Females on Hormonal Replacement therapy (HRT ), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if participants wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study.

   Regulation

6. Provide written informed consent prior to undertaking any study-related procedures.
7. Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study:

Medical history and clinical status

1. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).
3. Made a blood donation of any volume within 2 months prior to the first dose.
4. Symptomatic postural hypotension, irrespective of actual decrease in blood pressure, or asymptomatic postural hypotension with a decrease in systolic blood pressure ≥30 mmHg within 3 minutes of moving from supine to standing position.
5. Presence or history of drug hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician.
6. Known hypersensitivity to any component of the IMP formulation.
7. History or presence of drug or alcohol abuse (defined as alcohol consumption more than 2 units per day on a regular basis).
8. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled.

9. Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day).

   Interfering substances

10. Any medication, including St John's Wort, within 14 days prior to administration of the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception, menopausal hormone replacement therapy, or occasional paracetamol at doses up to 2g/day.
11. Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration.

12. Any vaccination in the 28 days prior to administration of the first dose.

    General conditions

13. Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development.
14. Any participant who enrolled in or participated in any other clinical study involving an investigational medicinal product, or in any other type of medical research within 1 month or within 5 times the elimination half-life prior to administration of the first dose.
15. Any participant who cannot be contacted in the case of an emergency.

16. Any participant who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor.

    Biological status

17. Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBcAb), anti-hepatitis C virus antibodies (anti-HCV), anti-human immunodeficiency virus 1 and 2 antibodies（anti-HIV1 and anti-HIV2 Ab).
18. Positive alcohol test.
19. Any participant in whom venous blood collection is difficult.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IPG1094 100 mg SAD; Four subjects in this cohort will receive a single dose of IPG1094 100 mg and two subjects will receive a single dose of placebo 100 mg orally.	Drug: IPG1094 100 mg SAD; a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets
Experimental: IPG1094 300 mg SAD; Six subjects in this cohort will receive a single dose of IPG1094 300 mg and two subjects will receive a single dose of placebo 300 mg orally.	Drug: IPG1094 300 mg SAD; a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets
Experimental: IPG1094 600 mg SAD; Six subjects in this cohort will receive a single dose of IPG1094 600 mg and two subjects will receive a single dose of placebo 600mg orally.	Drug: IPG1094 600 mg SAD; A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets
Experimental: IPG1094 900mg SAD; Six subjects in this cohort will receive a single dose of IPG1094 900 mg qd and two subjects will receive a single dose of placebo 900mg qd orally.	Drug: IPG1094 900 mg SAD; A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets
Experimental: IPG1094 1200mg SAD; Six subjects in this cohort will receive a single dose of IPG1094 1200 mg and two subjects will receive a single dose of placebo 1200 mg orally.	Drug: IPG1094 1200 mg SAD; A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets
Experimental: IPG1094 600 mg MAD QD; Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD. Subjects are discharged on Day 14, followed by a 7-day post-dosing follow-up. Six subjects in this cohort will receive IPG1094 600 mg and two subjects will receive placebo.	Drug: IPG1094 600 mg MAD QD; Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.
Experimental: IPG1094 200 mg MAD BID; Dosing begins on Day 1 and continues for 10 days with twice daily 200 mg. Subjects are discharged on Day 14, followed by a 7-day post-dosing follow-up. Six subjects in this cohort will receive IPG1094 200 mg nd two subjects will receive placebo.	Drug: IPG1094 200 mg MAD BID; Dosing starts on Day 1 and extends over a 10-day period. Subjects are discharged on Day 13, with a follow-up 7 days after the last dose, each cohort comprises approximately eight subjects, with 6 subjects on IPG1094 and 2 subjects on placebo
Experimental: IPG1094 300 mg MAD BID; Dosing begins on Day 1 and continues for 10 days with twice daily 300 mg. Subjects are discharged on Day 14, followed by a 7-day post-dosing follow-up. Six subjects in this cohort will receive IPG1094 300 mg and two subjects will receive placebo.	Drug: IPG1094 300 mg MAD BID; Dosing starts on Day 1 and extends over a 10-day period. Subjects are discharged on Day 13, with a follow-up 7 days after the last dose, each cohort comprises approximately eight subjects, with 6 subjects on IPG1094 and 2 subjects on placebo
Experimental: IPG1094 300 mg Fasted-Fed; For Cohort FE-1, Six subjects administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fasted condition, and Day 5 (anticipated) of Period 2 under the fed condition. 300 mg per administration.	Drug: IPG1094 300 mg Fasted-Fed; For Cohort FE-1, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fasted condition, and Day 5 (anticipated) of Period 2 under the fed condition.
Experimental: Part D IPG1094 300 mg Fed-Fasted; For Cohort FE-2, Six subjects administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fed condition, and Day 5 (anticipated) of Period 2 under fasted condition. 300 mg per administration.	Drug: IPG1094 300 mg Fed-Fasted; For Cohort FE-2, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fed condition, and Day 5 (anticipated) of Period 2 under fasted condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Evaluation of adverse events	Part A (SAD)：From signed ICF up to D8；Part B (MAD)：From signed ICF up to D17；Part C (MAD)：From signed ICF up to D17；Part D (FE)：From signed ICF up to D12；

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed concentration Part A: at 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: at 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration.	Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
Tmax	Time of maximum observed concentration Part A: at 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: at 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration.	Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
AUC0-t	The parameter would be calculated using the linear trapezoidal rule: Linear up log down. Part A: 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration	Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
CL/F	Apparent clearance following extravascular administration, calculated as Dose/AUC0-inf Part A: 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration	Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12

Collaborators and Investigators

• Sponsor: Nanjing Immunophage Biotech Co., Ltd
• Investigators: Principal Investigator: Christopher Argent, Scientia Clinical Research Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Additional Relevant MeSH Terms: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena; Physical Examination; Body Size; Body Weights and Measures; Body Constitution; Anthropometry; Sagittal Abdominal Diameter
• Other Study ID Numbers: IPG1094-A001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No