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

NCT05112159 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: IPG1094-A001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cmax

  Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12

• Tmax

  Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12

• AUC0-t

  Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12

• CL/F

  Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12

Study Arms (10)

IPG1094 100 mg SAD

EXPERIMENTAL

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

IPG1094 300 mg SAD

EXPERIMENTAL

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

IPG1094 600 mg SAD

EXPERIMENTAL

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

IPG1094 900mg SAD

EXPERIMENTAL

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

IPG1094 1200mg SAD

EXPERIMENTAL

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

IPG1094 600 mg MAD QD

EXPERIMENTAL

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

IPG1094 200 mg MAD BID

EXPERIMENTAL

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

IPG1094 300 mg MAD BID

EXPERIMENTAL

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

IPG1094 300 mg Fasted-Fed

EXPERIMENTAL

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

Part D IPG1094 300 mg Fed-Fasted

EXPERIMENTAL

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

Interventions

IPG1094 300 mg SAD DRUG

a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets

IPG1094 300 mg SAD

IPG1094 600 mg SAD DRUG

A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets

IPG1094 600 mg SAD

IPG1094 900 mg SAD DRUG

A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets

IPG1094 900mg SAD

IPG1094 1200 mg SAD DRUG

A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets

IPG1094 1200mg SAD

IPG1094 600 mg MAD QD DRUG

Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.

IPG1094 600 mg MAD QD

IPG1094 200 mg MAD BID DRUG

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

IPG1094 200 mg MAD BID

IPG1094 300 mg MAD BID DRUG

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

IPG1094 300 mg MAD BID

IPG1094 300 mg Fed-Fasted DRUG

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.

Part D IPG1094 300 mg Fed-Fasted

IPG1094 300 mg Fasted-Fed DRUG

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.

IPG1094 300 mg Fasted-Fed

IPG1094 100 mg SAD DRUG

a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets

IPG1094 100 mg SAD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be included in the study:
• Demography
• Healthy adult male or female participants between 18 and 50 years of age (inclusive).
• Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18\~32 kg/m2 (inclusive).
• Health status
• 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).
• A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• 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
• Provide written informed consent prior to undertaking any study-related procedures.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• Medical history and clinical status
• 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.
• Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).
• Made a blood donation of any volume within 2 months prior to the first dose.
• 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.
• Presence or history of drug hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician.
• Known hypersensitivity to any component of the IMP formulation.
• History or presence of drug or alcohol abuse (defined as alcohol consumption more than 2 units per day on a regular basis).
• 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.
• Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day).
• Interfering substances
• 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.
• Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration.
• Any vaccination in the 28 days prior to administration of the first dose.

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Interventions

Sagittal Abdominal Diameter

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Results Point of Contact

• Title: WangJianfei/CSO
• Organization: Nanjing Immunophage Biotech Co., Ltd.

jfwang@immunophage.com.cn

+8602134782827

Study Officials

• Christopher Argent

  Scientia Clinical Research Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment (for SAD and MAD) and Crossover Assignment (for Food Effect)

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: November 8, 2021
• Study Start: September 27, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)