Healthy VolunteersPhase 1NCT05112159
Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants
A Phase 1 study testing IPG1094 300 mg SAD, IPG1094 600 mg SAD and IPG1094 900 mg SAD in people with Healthy Volunteers, run by Nanjing Immunophage Biotech Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IPG1094 300 mg SAD, IPG1094 600 mg SAD and IPG1094 900 mg SAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Sep 2021to 25 Jul 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- IPG1094 300 mg SAD, IPG1094 600 mg SAD, IPG1094 900 mg SAD, IPG1094 1200 mg SAD, IPG1094 600 mg MAD QD
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG1094 300 mg SADDrug
a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets
IPG1094 600 mg SADDrug
A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets
IPG1094 900 mg SADDrug
A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets
IPG1094 1200 mg SADDrug
A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets
IPG1094 600 mg MAD QDDrug
Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.
IPG1094 200 mg MAD BIDDrug
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 BIDDrug
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-FastedDrug
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-FedDrug
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 SADDrug
a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: IPG1094 300 mg Fed-Fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Evaluation of adverse events
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start27 Sep 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment (for SAD and MAD) and Crossover Assignment (for Food Effect)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Immunophage Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Argent, Principal investigator, Scientia Clinical Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112159
- Sponsor's protocol ID
- IPG1094-A001
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2021
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05112159
- Acronym / sponsor ID
- IPG1094-A001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Nanjing Immunophage Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- Parallel Assignment (for SAD and MAD) and Crossover Assignment (for Food Effect)
| Arm | Type | Receives |
|---|---|---|
| IPG1094 100 mg SAD | Experimental | Drug: IPG1094 100 mg SADFour 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 300 mg SAD | Experimental | Drug: IPG1094 300 mg SADSix 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. |
| IPG1094 600 mg SAD | Experimental | Drug: IPG1094 600 mg SADSix 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. |
| IPG1094 900mg SAD | Experimental | Drug: IPG1094 900 mg SADSix 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. |
| IPG1094 1200mg SAD | Experimental | Drug: IPG1094 1200 mg SADSix 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. |
| IPG1094 600 mg MAD QD | Experimental | Drug: IPG1094 600 mg MAD QDDosing 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 | Drug: IPG1094 200 mg MAD BIDDosing 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 | Drug: IPG1094 300 mg MAD BIDDosing 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 | Drug: IPG1094 300 mg Fasted-FedFor 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 | Drug: IPG1094 300 mg Fed-FastedFor 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG1094 300 mg SADa Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets | Drug | IPG1094 300 mg SAD |
| IPG1094 600 mg SADA Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets | Drug | IPG1094 600 mg SAD |
| IPG1094 900 mg SADA Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets | Drug | IPG1094 900mg SAD |
| IPG1094 1200 mg SADA Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets | Drug | IPG1094 1200mg SAD |
| IPG1094 600 mg MAD QDDosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD. | Drug | IPG1094 600 mg MAD QD |
| IPG1094 200 mg MAD BIDDosing 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 | Drug | IPG1094 200 mg MAD BID |
| IPG1094 300 mg MAD BIDDosing 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 | Drug | IPG1094 300 mg MAD BID |
| IPG1094 300 mg Fed-FastedFor 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. | Drug | Part D IPG1094 300 mg Fed-Fasted |
| IPG1094 300 mg Fasted-FedFor 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. | Drug | IPG1094 300 mg Fasted-Fed |
| IPG1094 100 mg SADa Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets | Drug | IPG1094 100 mg SAD |
Primary outcome
Adverse Events
Time frame: 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；
Evaluation of adverse events
4 secondary outcomes
Cmax
Time frame: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
Tmax
Time frame: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
AUC0-t
Time frame: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
CL/F
Time frame: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Argent principal investigator
Scientia Clinical Research Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPG1094 300 mg SAD, IPG1094 600 mg SAD and IPG1094 900 mg SAD in people with Healthy Volunteers, run by Nanjing Immunophage Biotech Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 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；). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.