Trial Outcomes & Findings for Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants (NCT NCT05112159)
NCT ID: NCT05112159
Last Updated: 2026-05-01
Results Overview
Evaluation of adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
76 participants
Primary outcome timeframe
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；
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
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.
|
Part A : 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
PartB: Placebo
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
6
|
6
|
6
|
6
|
7
|
6
|
10
|
2
|
4
|
7
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
6
|
6
|
4
|
6
|
0
|
10
|
2
|
2
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
6
|
0
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Part A : 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
PartB: Placebo
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants
Baseline characteristics by cohort
| Measure |
IPG1094 300 mg SAD
n=6 Participants
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
|
IPG1094 100 mg SAD
n=4 Participants
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
|
IPG1094 600 mg SAD
n=6 Participants
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
|
IPG1094 900mg SAD
n=6 Participants
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
|
IPG1094 1200mg SAD
n=6 Participants
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
|
IPG1094 600 mg MAD QD
n=6 Participants
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.
|
IPG1094 200 mg MAD BID
n=7 Participants
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
|
IPG1094 300 mg MAD BID
n=6 Participants
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
|
PartA: Placebo
n=10 Participants
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
|
PartB: Placebo
n=2 Participants
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
Part C： Placebo
n=4 Participants
Total subjects in 200mg and 300mg MAD BID receive dose of placebo 200mg,300 mg bid orally，respectively. 2 subjects per each dose.
|
Part D IPG1094 300 mg Fasted-Fed
n=7 Participants
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
n=6 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
6 Participants
n=69 Participants
|
6 Participants
n=140 Participants
|
6 Participants
n=451 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=162 Participants
|
6 Participants
n=19729 Participants
|
10 Participants
n=221228 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
76 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 9.59 • n=14 Participants
|
27.3 years
STANDARD_DEVIATION 5.25 • n=34 Participants
|
29.3 years
STANDARD_DEVIATION 6.28 • n=69 Participants
|
28.7 years
STANDARD_DEVIATION 5.01 • n=140 Participants
|
26.3 years
STANDARD_DEVIATION 3.14 • n=451 Participants
|
32.3 years
STANDARD_DEVIATION 4.55 • n=27 Participants
|
29.4 years
STANDARD_DEVIATION 5.44 • n=162 Participants
|
31.0 years
STANDARD_DEVIATION 9.53 • n=19729 Participants
|
27.8 years
STANDARD_DEVIATION 5.27 • n=221228 Participants
|
33.5 years
STANDARD_DEVIATION 6.36 • n=30 Participants
|
27.5 years
STANDARD_DEVIATION 4.65 • n=8 Participants
|
30.1 years
STANDARD_DEVIATION 5.18 • n=3 Participants
|
30.2 years
STANDARD_DEVIATION 1.72 • n=3 Participants
|
29.6 years
STANDARD_DEVIATION 5.79 • n=1 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
4 Participants
n=140 Participants
|
2 Participants
n=451 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=162 Participants
|
2 Participants
n=19729 Participants
|
4 Participants
n=221228 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
35 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=140 Participants
|
4 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=162 Participants
|
4 Participants
n=19729 Participants
|
6 Participants
n=221228 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
41 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=162 Participants
|
3 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
19 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
4 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=162 Participants
|
3 Participants
n=19729 Participants
|
10 Participants
n=221228 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
51 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=162 Participants
|
1 Participants
n=19729 Participants
|
2 Participants
n=221228 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
15 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
6 Participants
n=140 Participants
|
6 Participants
n=451 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=162 Participants
|
5 Participants
n=19729 Participants
|
8 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
61 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
|
BMI
|
24.2 kg/m²
STANDARD_DEVIATION 3.105 • n=14 Participants
|
24.45 kg/m²
STANDARD_DEVIATION 3.515 • n=34 Participants
|
23.07 kg/m²
STANDARD_DEVIATION 1.969 • n=69 Participants
|
27.88 kg/m²
STANDARD_DEVIATION 2.169 • n=140 Participants
|
23.02 kg/m²
STANDARD_DEVIATION 3.043 • n=451 Participants
|
25.88 kg/m²
STANDARD_DEVIATION 3.274 • n=27 Participants
|
26.26 kg/m²
STANDARD_DEVIATION 2.985 • n=162 Participants
|
24.88 kg/m²
STANDARD_DEVIATION 2.841 • n=19729 Participants
|
25.09 kg/m²
STANDARD_DEVIATION 3.446 • n=221228 Participants
|
23.1 kg/m²
STANDARD_DEVIATION 0.566 • n=30 Participants
|
25.23 kg/m²
STANDARD_DEVIATION 2.311 • n=8 Participants
|
24.67 kg/m²
STANDARD_DEVIATION 2.969 • n=3 Participants
|
23.32 kg/m²
STANDARD_DEVIATION 1.426 • n=3 Participants
|
24.63 kg/m²
STANDARD_DEVIATION 3.198 • n=1 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
PartA: IPG1094 100 mg SAD
n=4 Participants
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
|
PartA: IPG1094 300 mg SAD
n=6 Participants
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
|
PartA: IPG1094 600 mg SAD
n=6 Participants
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
|
PartA: IPG1094 900mg SAD
n=6 Participants
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
|
PartA: IPG1094 1200mg SAD
n=6 Participants
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
|
Part C: IPG1094 300 mg MAD BID
n=6 Participants
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.
|
PartB: IPG1094 600 mg MAD QD
n=6 Participants
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.
|
Part C: IPG1094 200 mg MAD BID
n=6 Participants
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.
|
Part D:IPG1094 300mg Fasted
n=12 Participants
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
|
PartD: IPG1094 300mg Fed
n=12 Participants
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
|
PartA: Placebo
n=10 Participants
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.
|
PartB: Placebo
n=2 Participants
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
Part C： Placebo
n=4 Participants
Total subjects in 200mg and 300mg MAD BID receive dose of placebo 200mg,300 mg bid orally，respectively. 2 subjects per each dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12Population: 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
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.
Outcome measures
| Measure |
PartA: IPG1094 100 mg SAD
n=4 Participants
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
|
PartA: IPG1094 300 mg SAD
n=6 Participants
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
|
PartA: IPG1094 600 mg SAD
n=6 Participants
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
|
PartA: IPG1094 900mg SAD
n=6 Participants
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
|
PartA: IPG1094 1200mg SAD
n=6 Participants
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
|
Part C: IPG1094 300 mg MAD BID
n=6 Participants
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.
|
PartB: IPG1094 600 mg MAD QD
n=6 Participants
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.
|
Part C: IPG1094 200 mg MAD BID
n=6 Participants
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.
|
Part D:IPG1094 300mg Fasted
n=12 Participants
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
|
PartD: IPG1094 300mg Fed
n=12 Participants
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
|
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.
|
PartB: Placebo
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
the SAD group and the single-dose administration (D1) of the MAD group and fasted &Fed status
|
508 ng/mL
Standard Deviation 262
|
2180 ng/mL
Standard Deviation 1000
|
5500 ng/mL
Standard Deviation 2160
|
8330 ng/mL
Standard Deviation 3030
|
18800 ng/mL
Standard Deviation 6250
|
4650 ng/mL
Standard Deviation 2480
|
4860 ng/mL
Standard Deviation 2370
|
1400 ng/mL
Standard Deviation 699
|
2280 ng/mL
Standard Deviation 1880
|
5630 ng/mL
Standard Deviation 2230
|
—
|
—
|
—
|
|
Cmax
The Cmax data of the MAD group after multiple administrations (D10)
|
—
|
—
|
—
|
—
|
—
|
—
|
15800 ng/mL
Standard Deviation 17500
|
8830 ng/mL
Standard Deviation 2860
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12Population: 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.
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.
Outcome measures
| Measure |
PartA: IPG1094 100 mg SAD
n=4 Participants
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
|
PartA: IPG1094 300 mg SAD
n=6 Participants
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
|
PartA: IPG1094 600 mg SAD
n=6 Participants
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
|
PartA: IPG1094 900mg SAD
n=6 Participants
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
|
PartA: IPG1094 1200mg SAD
n=6 Participants
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
|
Part C: IPG1094 300 mg MAD BID
n=6 Participants
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.
|
PartB: IPG1094 600 mg MAD QD
n=6 Participants
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.
|
Part C: IPG1094 200 mg MAD BID
n=6 Participants
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.
|
Part D:IPG1094 300mg Fasted
n=12 Participants
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
|
PartD: IPG1094 300mg Fed
n=12 Participants
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
|
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.
|
PartB: Placebo
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax
the SAD group and the single-dose administration (D1) of the MAD group and fasted &Fed status
|
3.19 h
Interval 2.52 to 5.7
|
2.55 h
Interval 2.42 to 3.92
|
5.91 h
Interval 2.45 to 6.0
|
2.98 h
Interval 2.45 to 9.0
|
7.49 h
Interval 4.0 to 9.0
|
3.98 h
Interval 3.0 to 4.0
|
3.04 h
Interval 2.43 to 3.92
|
2.03 h
Interval 1.15 to 4.2
|
4.36 h
Interval 1.42 to 12.07
|
4.81 h
Interval 1.97 to 9.0
|
—
|
—
|
—
|
|
Tmax
The Tmax data of the MAD group after multiple administrations (D10)
|
—
|
—
|
—
|
—
|
—
|
—
|
2.72 h
Interval 2.3 to 6.28
|
1.43 h
Interval 0.92 to 6.03
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12Population: 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.
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
Outcome measures
| Measure |
PartA: IPG1094 100 mg SAD
n=4 Participants
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
|
PartA: IPG1094 300 mg SAD
n=6 Participants
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
|
PartA: IPG1094 600 mg SAD
n=6 Participants
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
|
PartA: IPG1094 900mg SAD
n=6 Participants
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
|
PartA: IPG1094 1200mg SAD
n=6 Participants
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
|
Part C: IPG1094 300 mg MAD BID
n=6 Participants
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.
|
PartB: IPG1094 600 mg MAD QD
n=6 Participants
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.
|
Part C: IPG1094 200 mg MAD BID
n=6 Participants
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.
|
Part D:IPG1094 300mg Fasted
n=12 Participants
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
|
PartD: IPG1094 300mg Fed
n=12 Participants
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
|
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.
|
PartB: Placebo
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-t
the SAD group and the single-dose administration (D1) of the MAD group and fasted &Fed status
|
5950 h*ng/mL
Standard Deviation 1520
|
26100 h*ng/mL
Standard Deviation 14100
|
85600 h*ng/mL
Standard Deviation 40200
|
157000 h*ng/mL
Standard Deviation 93400
|
345000 h*ng/mL
Standard Deviation 151000
|
28900 h*ng/mL
Standard Deviation 16700
|
55200 h*ng/mL
Standard Deviation 36900
|
8500 h*ng/mL
Standard Deviation 5630
|
29700 h*ng/mL
Standard Deviation 37100
|
48800 h*ng/mL
Standard Deviation 30900
|
—
|
—
|
—
|
|
AUC0-t
the MAD group after multiple administrations (D10)
|
—
|
—
|
—
|
—
|
—
|
—
|
195000 h*ng/mL
Standard Deviation 239000
|
63000 h*ng/mL
Standard Deviation 25500
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12Population: 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.
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
Outcome measures
| Measure |
PartA: IPG1094 100 mg SAD
n=4 Participants
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
|
PartA: IPG1094 300 mg SAD
n=6 Participants
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
|
PartA: IPG1094 600 mg SAD
n=6 Participants
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
|
PartA: IPG1094 900mg SAD
n=6 Participants
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
|
PartA: IPG1094 1200mg SAD
n=6 Participants
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
|
Part C: IPG1094 300 mg MAD BID
n=6 Participants
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.
|
PartB: IPG1094 600 mg MAD QD
n=6 Participants
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.
|
Part C: IPG1094 200 mg MAD BID
n=6 Participants
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.
|
Part D:IPG1094 300mg Fasted
n=12 Participants
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
|
PartD: IPG1094 300mg Fed
n=12 Participants
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
|
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.
|
PartB: Placebo
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F
the SAD group and the single-dose administration (D1) of the MAD group and fasted &Fed status
|
14.8 L/h
Standard Deviation 3.73
|
13.7 L/h
Standard Deviation 7.62
|
9.07 L/h
Standard Deviation 5.94
|
8.45 L/h
Standard Deviation 6.18
|
4.21 L/h
Standard Deviation 2.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F
the MAD group after multiple administrations (D10)
|
—
|
—
|
—
|
—
|
—
|
—
|
7.44 L/h
Standard Deviation 5.59
|
3.68 L/h
Standard Deviation 1.64
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
IPG1094 100 mg SAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IPG1094 300 mg SAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
IPG1094 600 mg SAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IPG1094 900mg SAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IPG1094 1200mg SAD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IPG1094 600 mg MAD QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IPG1094 200 mg MAD BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IPG1094 300 mg MAD BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part D:Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part D: Fed
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PartA: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PartB: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C： Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IPG1094 100 mg SAD
n=4 participants at risk
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
|
IPG1094 300 mg SAD
n=6 participants at risk
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
|
IPG1094 600 mg SAD
n=6 participants at risk
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
|
IPG1094 900mg SAD
n=6 participants at risk
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
|
IPG1094 1200mg SAD
n=6 participants at risk
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
|
IPG1094 600 mg MAD QD
n=6 participants at risk
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.
|
IPG1094 200 mg MAD BID
n=6 participants at risk
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
|
IPG1094 300 mg MAD BID
n=6 participants at risk
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
|
Part D:Fasted
n=12 participants at risk
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
|
Part D: Fed
n=12 participants at risk
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
|
PartA: Placebo
n=10 participants at risk
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.
|
PartB: Placebo
n=2 participants at risk
2 subjects in 600mg MAD receive dose of placebo 600mg qd orally
|
Part C： Placebo
n=4 participants at risk
Total subjects in 200mg and 300mg MAD BID receive dose of placebo 200mg,300 mg bid orally，respectively. 2 subjects per each dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/4 • 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；
|
16.7%
1/6 • 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；
|
33.3%
2/6 • 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；
|
33.3%
2/6 • 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；
|
100.0%
6/6 • 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；
|
100.0%
6/6 • 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；
|
83.3%
5/6 • 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；
|
100.0%
6/6 • 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；
|
33.3%
4/12 • 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；
|
41.7%
5/12 • 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；
|
10.0%
1/10 • 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；
|
100.0%
2/2 • 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；
|
50.0%
2/4 • 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；
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/4 • 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；
|
0.00%
0/6 • 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；
|
33.3%
2/6 • 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；
|
0.00%
0/6 • 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；
|
66.7%
4/6 • 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；
|
50.0%
3/6 • 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；
|
33.3%
2/6 • 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；
|
83.3%
5/6 • 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；
|
0.00%
0/12 • 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；
|
0.00%
0/12 • 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；
|
0.00%
0/10 • 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；
|
50.0%
1/2 • 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；
|
25.0%
1/4 • 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；
|
|
General disorders
General disorders and administration site conditions
|
0.00%
0/4 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
8.3%
1/12 • 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；
|
8.3%
1/12 • 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；
|
10.0%
1/10 • 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；
|
0.00%
0/2 • 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；
|
25.0%
1/4 • 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；
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/4 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/12 • 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；
|
8.3%
1/12 • 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；
|
10.0%
1/10 • 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；
|
0.00%
0/2 • 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；
|
0.00%
0/4 • 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；
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/4 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
16.7%
1/6 • 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；
|
33.3%
2/6 • 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；
|
33.3%
2/6 • 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；
|
0.00%
0/12 • 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；
|
8.3%
1/12 • 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；
|
0.00%
0/10 • 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；
|
0.00%
0/2 • 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；
|
0.00%
0/4 • 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；
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/4 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
16.7%
1/6 • 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；
|
0.00%
0/12 • 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；
|
0.00%
0/12 • 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；
|
0.00%
0/10 • 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；
|
0.00%
0/2 • 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；
|
0.00%
0/4 • 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；
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/4 • 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；
|
16.7%
1/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/12 • 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；
|
0.00%
0/12 • 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；
|
30.0%
3/10 • 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；
|
0.00%
0/2 • 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；
|
0.00%
0/4 • 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；
|
|
Investigations
Investigations
|
0.00%
0/4 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
0.00%
0/6 • 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；
|
16.7%
1/6 • 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；
|
8.3%
1/12 • 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；
|
8.3%
1/12 • 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；
|
0.00%
0/10 • 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；
|
0.00%
0/2 • 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；
|
0.00%
0/4 • 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；
|
Additional Information
WangJianfei/CSO
Nanjing Immunophage Biotech Co., Ltd.
Phone: +8602134782827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place