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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| 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； |
| 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. |
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Inclusion Criteria:
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.
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
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.
General conditions
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.
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.
Any participant who cannot be contacted in the case of an emergency.
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
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).
Positive alcohol test.
Any participant in whom venous blood collection is difficult.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Argent | Scientia Clinical Research Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Ltd | Randwick | New South Wales | 2031 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A :100 mg SAD | In Cohort 1, 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. |
| FG001 | Part A : 300 mg SAD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2022 | Feb 27, 2026 |
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Parallel Assignment (for SAD and MAD) and Crossover Assignment (for Food Effect)
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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 |
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| 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 |
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| 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 |
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| IPG1094 600 mg MAD QD | Drug | Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD. |
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| 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 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 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. |
|
| 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 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 |
|
| 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 |
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.
| FG002 | Part A : 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. |
| FG003 | Part A : 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. |
| FG004 | Part A : 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. |
| FG005 | Part B : 600 mg QD MAD | 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. |
| FG006 | Part C : 200 mg BID MAD | 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 and two subjects will receive placebo. |
| FG007 | Part C : 300 mg BID MAD | 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. |
| FG008 | PartA: Placebo | Total subjects in cohort SAD receive a single dose of placebo 100mg,300 mg,600 mg,900 mg,1200mg qd orally，respectively. 2 subjects per each dose. |
| FG009 | PartB: Placebo | 2 subjects in 600mg MAD receive dose of placebo 600mg qd orally |
| FG010 | Part C： Placebo | Total subjects in 200mg and 300mg MAD BID receive dose of placebo 200mg,300 mg bid orally，respectively. 2 subjects per each dose. |
| FG011 | Part D 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. |
| FG012 | Part D 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. placebo: Matched placebo tablets IPG1094 300 mg single dose: a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days |
| BG001 | IPG1094 100 mg SAD | In Cohort 1, 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. IPG1094 100 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days placebo: Matched placebo tablets |
| BG002 | 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. placebo: Matched placebo tablets IPG1094 600 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days |
| BG003 | 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. placebo: Matched placebo tablets IPG1094 900 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days |
| BG004 | 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. placebo: Matched placebo tablets IPG1094 1200 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days |
| BG005 | 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. placebo: Matched placebo tablets IPG1094 600 mg MAD QD: Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD. |
| BG006 | 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 and two subjects will receive placebo. placebo: Matched placebo tablets 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 |
| BG007 | 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 200 mg and two subjects will receive placebo. placebo: Matched placebo tablets 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 |
| BG008 | PartA: Placebo | In Cohort 1, 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. IPG1094 100 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days placebo: Matched placebo tablets |
| BG009 | PartB: Placebo | 2 subjects in 600mg MAD receive dose of placebo 600mg qd orally |
| BG010 | Part C： Placebo | Total subjects in 200mg and 300mg MAD BID receive dose of placebo 200mg,300 mg bid orally，respectively. 2 subjects per each dose. |
| BG011 | Part D 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. |
| BG012 | 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. |
| BG013 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m² |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Adverse Events | Evaluation of adverse events | Posted | Count of Participants | Participants | No | 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； |
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| Secondary | 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. | For the 300 mg MAD BID cohort, no PK data were collected on Day 10, as all 6 enrolled participants in this cohort did not complete the study. Additionally, no Day 10 PK data were obtained for all SAD cohorts, as well as the food-effect cohorts (both fasted and fed states), due to the study design: these cohorts no multiple administrations scheduled for Day 10, and thus no PK sampling was performed at this time point. Consequently, the number of particip | Posted | Mean | Standard Deviation | ng/mL | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 |
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| Secondary | 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. | For the 300 mg MAD BID cohort, no Day 10 PK data were collected as all 6 enrolled participants did not complete the study. No Day 10 PK data were obtained for all SAD cohorts and food-effect cohorts (fasted/fed states), as no PK sampling was performed at Day 10. Thus, the number of participants analyzed for these cohorts on Day 10 is 0, differing from the overall enrolled number. | Posted | Median | Full Range | h | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 |
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| Secondary | 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 | For the 300 mg MAD BID cohort, no Day 10 PK data were collected as all 6 enrolled participants did not complete the study. No Day 10 PK data were obtained for all SAD cohorts and food-effect cohorts (fasted/fed states), as no PK sampling was performed at Day 10. Thus, the number of participants analyzed for these cohorts on Day 10 is 0, differing from the overall enrolled number. | Posted | Mean | Standard Deviation | h*ng/mL | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 |
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| Secondary | 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 | For the MAD cohort, no CL/F data were available at Day 1. For food-effect cohorts, no CL/F data were reported at Day 1 or Day 10 as this parameter is not applicable. For SAD cohorts, no CL/F data were available at Day 10 as no PK sampling was performed at this time point. Accordingly, the number of participants analyzed for these cohorts at the corresponding time points is 0. | Posted | Mean | Standard Deviation | L/h | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 |
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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；
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IPG1094 100 mg SAD | In Cohort 1, 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. IPG1094 100 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days placebo: Matched placebo tablets | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | 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. placebo: Matched placebo tablets IPG1094 300 mg single dose: a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | 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. placebo: Matched placebo tablets IPG1094 600 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | 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. placebo: Matched placebo tablets IPG1094 900 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | 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. placebo: Matched placebo tablets IPG1094 1200 mg single dose: A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | 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. placebo: Matched placebo tablets IPG1094 600 mg MAD QD: Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | 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 and two subjects will receive placebo. placebo: Matched placebo tablets 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 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG007 | 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 200 mg and two subjects will receive placebo. placebo: Matched placebo tablets 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 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG008 | Part D:Fasted | Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2;Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 | 0 | 12 | 0 | 12 | 5 | 12 |
| EG009 | Part D: Fed | Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2;Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 | 0 | 12 | 0 | 12 | 7 | 12 |
| EG010 | PartA: Placebo | Total subjects in cohort SAD receive a single dose of placebo 100mg,300 mg,600 mg,900 mg,1200mg qd orally，respectively. 2 subjects per each dose. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG011 | PartB: Placebo | 2 subjects in 600mg MAD receive dose of placebo 600mg qd orally | 0 | 2 | 0 | 2 | 2 | 2 |
| EG012 | Part C： Placebo | Total subjects in 200mg and 300mg MAD BID receive dose of placebo 200mg,300 mg bid orally，respectively. 2 subjects per each dose. | 0 | 4 | 0 | 4 | 2 | 4 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| WangJianfei/CSO | Nanjing Immunophage Biotech Co., Ltd. | +8602134782827 | jfwang@immunophage.com.cn |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2022 | Jan 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| OG001 | Part A: 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. |
| OG002 | Part A: 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. |
| OG003 | Part A: 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. |
| OG004 | Part A: 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. |
| OG005 | Part B: 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. |
| OG006 | Part C: 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. |
| OG007 | Part C: 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. |
| OG008 | Part D: IPG1094 300mg Fasted | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fasted state of the Cohort FE-1 and FE-2 |
| OG009 | PartD: IPG1094 300mg Fed | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fed state of the Cohort FE-1 and FE-2 |
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| OG001 | Part A: 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. |
| OG002 | Part A: 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. |
| OG003 | Part A: 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. |
| OG004 | Part A: 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. |
| OG005 | Part B: 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. |
| OG006 | Part C: 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. |
| OG007 | Part C: 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. |
| OG008 | PartD: IPG1094 300mg Fasted | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fasted state of the Cohort FE-1 and FE-2 |
| OG009 | PartD: IPG1094 300mg Fed | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fed state of the Cohort FE-1 and FE-2 |
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| OG001 | PartA：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. |
| OG002 | Part A：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. |
| OG003 | Part A：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. |
| OG004 | PartA：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. |
| OG005 | Part B：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. |
| OG006 | Part C：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. |
| OG007 | PartC：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. |
| OG008 | Part D： IPG1094 300 mg Fasted | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fasted state of the Cohort FE-1 and FE-2 |
| OG009 | PartD: IPG1094 300mg Fed | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fed state of the Cohort FE-1 and FE-2 |
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| OG001 | Part A: 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. |
| OG002 | Part A: 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. |
| OG003 | Part A: 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. |
| OG004 | Part A: 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. |
| OG005 | Part B: 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. |
| OG006 | Part C: 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. |
| OG007 | Part C: 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. |
| OG008 | Part D： IPG1094 300 mg Fasted | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fasted state of the Cohort FE-1 and FE-2 |
| OG009 | PartD: IPG1094 300mg Fed | For Cohort FE-1, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fasted state with 240 mL on Day 1 of Period 1, and in fed state with 240 mL on Day 1 of Period 2; For Cohort FE-2, Subjects would be administered with a single dose of assigned study drug (IPG1094) in fed state with 240 mL on Day 1 of Period 1, and in fasted state with 240 mL on Day 1 of Period 2 Analyze patients in the fed state of the Cohort FE-1 and FE-2 |
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