Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
Brief summary
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of single dose orally administered IPG1094 in healthy adult participants.
Interventions
DRUGIPG1094 300 mg SAD
a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets
DRUGIPG1094 600 mg SAD
A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets
DRUGIPG1094 900 mg SAD
A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets
DRUGIPG1094 1200 mg SAD
A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets
DRUGIPG1094 600 mg MAD QD
Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.
DRUGIPG1094 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
DRUGIPG1094 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
DRUGIPG1094 300 mg Fed-Fasted
For Cohort FE-2, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fed condition, and Day 5 (anticipated) of Period 2 under fasted condition.
DRUGIPG1094 300 mg Fasted-Fed
For Cohort FE-1, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fasted condition, and Day 5 (anticipated) of Period 2 under the fed condition.
DRUGIPG1094 100 mg SAD
a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets
Sponsors
Nanjing Immunophage Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assignment (for SAD and MAD) and Crossover Assignment (for Food Effect)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following criteria to be included in the study: Demography 1. Healthy adult male or female participants between 18 and 50 years of age (inclusive). 2. Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18\~32 kg/m2 (inclusive). Health status 3. In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests. Vital signs (measured after resting for 5 minutes seated position) within normal range, or outside the normal range and not considered clinically significant by the Investigator. Standard 12-lead ECG parameters (recorded after resting for 5 minutes in supine position) in the following ranges; corrected QT interval(QTc) (Fridericia algorithm recommended) ≤ 450 ms for males and 470 ms for females, and normal ECG tracing, or abnormal ECG tracing not considered clinically relevant by the Investigator. Laboratory parameters demonstrating no clinically significant abnormalities, as determined by the Investigator. A total bilirubin outside the normal range may be acceptable if total bilirubin does not exceed 1.5 × upper limit of normal(ULN) conjugated bilirubin (with the exception of a participant with documented Gilbert syndrome). 4. A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). 5. Female participants must not be pregnant or breastfeeding and must use an effective contraception method (as described in Section 4.5.4), with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal. A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the Investigational Medicinal Product (IMP). The participant must be excluded from the study if the serum pregnancy test is positive. A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle stimulating hormone（FSH） measurement (\> 40 IU/L or milli-International unit（mIU）/mL).Females on Hormonal Replacement therapy (HRT ), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if participants wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study. Regulation 6. Provide written informed consent prior to undertaking any study-related procedures. 7. Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.
Exclusion criteria
Participants who meet any of the following criteria will be excluded from the study: Medical history and clinical status 1. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. 2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month). 3. Made a blood donation of any volume within 2 months prior to the first dose. 4. Symptomatic postural hypotension, irrespective of actual decrease in blood pressure, or asymptomatic postural hypotension with a decrease in systolic blood pressure ≥30 mmHg within 3 minutes of moving from supine to standing position. 5. Presence or history of drug hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician. 6. Known hypersensitivity to any component of the IMP formulation. 7. History or presence of drug or alcohol abuse (defined as alcohol consumption more than 2 units per day on a regular basis). 8. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled. 9. Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day). Interfering substances 10. Any medication, including St John's Wort, within 14 days prior to administration of the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception, menopausal hormone replacement therapy, or occasional paracetamol at doses up to 2g/day. 11. Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration. 12. Any vaccination in the 28 days prior to administration of the first dose. General conditions 13. Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development. 14. Any participant who enrolled in or participated in any other clinical study involving an investigational medicinal product, or in any other type of medical research within 1 month or within 5 times the elimination half-life prior to administration of the first dose. 15. Any participant who cannot be contacted in the case of an emergency. 16. Any participant who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor. Biological status 17. Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBcAb), anti-hepatitis C virus antibodies (anti-HCV), anti-human immunodeficiency virus 1 and 2 antibodies（anti-HIV1 and anti-HIV2 Ab). 18. Positive alcohol test. 19. Any participant in whom venous blood collection is difficult.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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； | Evaluation of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 | 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. |
| Tmax | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 | 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. |
| AUC0-t | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 | 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 |
| CL/F | Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12 | 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 |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORChristopher Argent
Scientia Clinical Research Ltd
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 29.6 years STANDARD_DEVIATION 5.79 |
| BMI | 24.2 kg/m² STANDARD_DEVIATION 3.105 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 2 / 6 | 3 / 6 | 3 / 6 | 6 / 6 | 6 / 6 | 6 / 6 | 6 / 6 | 5 / 12 | 7 / 12 | 5 / 10 | 2 / 2 | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 2 | 0 / 4 |
Outcome results
None listed