Trial Outcomes & Findings for Phase 1 Study for IPG11406 in Health Volunteer (NCT NCT06255834)

NCT ID: NCT06255834

Last Updated: 2026-04-17

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

66 participants

Primary outcome timeframe

from first dose until end of follow-up, up to 17 days

Results posted on

2026-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (SAD - 0.5 mg) 4 subjects receive a single dose of IPG11406 0.5 mg qd orally.	Cohort 2 (SAD - 2 mg) 4 subjects receive a single dose of IPG11406 2 mg qd orally.	Cohort 3 (SAD - 6 mg) 4 subjects receive a single dose of IPG11406 6 mg qd orally.	Cohort 4 (SAD - 20 mg) 6 subjects in this cohort will receive a single dose of IPG11406 20 mg qd	Cohort 5 (SAD - 40 mg) 6 subjects receive a single dose of IPG11406 40 mg qd orally.	Cohort 6 (SAD - 80 mg) 6 subjects receive a single dose of IPG11406 80 mg qd orally.	Cohort 7 (MAD - 10 mg) 6 subjects receive a dose of IPG11406 10 mg qd orally from Day 1 to 10-day.	Cohort 8 (MAD - 20 mg) 6 subjects receive a dose of IPG11406 20 mg qd orally from Day 1 to 10-day.	Cohort 9 (MAD - 40 mg) 6 subjects receive a dose of IPG11406 40 mg qd orally from Day 1 to 10-day.	Placebo（SAD） Total subjects in cohort SAD receive a single dose of placebo 0.5 mg,2 mg,6 mg,20 mg,40 mg,80 mg qd orally，respectively. 2 subjects per each dose.	Placebo（MAD） Total subjects in cohort MAD receive a dose of placebo 10 mg qd, 20 mg bid, 40 mg qd orally from Day 1 to 10-Day, respectivelly. 2 subjects per each dose.
Overall Study COMPLETED	4	4	4	6	6	6	6	6	6	12	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study STARTED	4	4	4	6	6	6	6	6	6	12	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1 Study for IPG11406 in Health Volunteer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (SAD - 0.5 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 0.5 mg qd orally.	Cohort 2 (SAD - 2 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 2 mg qd orally.	Cohort 3 (SAD - 6 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 6 mg qd orally.	Cohort 4 (SAD - 20 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 20 mg qd orally.	Cohort 5 (SAD - 40 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 40 mg qd orally.	Cohort 6 (SAD - 80 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 80 mg qd orally.	Cohort 7 (MAD - 10 mg) n=6 Participants 6 subjects receive a dose of IPG11406 10 mg qd orally from Day 1 to 10-day.	Cohort 8 (MAD - 20 mg) n=6 Participants 6 subjects receive a dose of IPG11406 20 mg bid orally from Day 1 to 10-day.	Cohort 9 (MAD - 40 mg) n=6 Participants 6 subjects receive a dose of IPG11406 40 mg qd orally from Day 1 to 10-day.	Placebo(SAD ) n=12 Participants Total subjects in cohort SAD receive a single dose of placebo 0.5 mg,2 mg,6 mg,20 mg,40 mg,80 mg qd orally，respectively. 2 subjects per each dose.	Placebo（MAD） n=6 Participants Total subjects in cohort MAD receive a dose of placebo 10 mg qd, 20 mg bid, 40 mg qd orally from Day 1 to 10-Day, respectivelly. 2 subjects per each dose.	Total n=132 Participants Total of all reporting groups
baseline height	170.50 cm STANDARD_DEVIATION 5.745 • n=4 Participants	168.13 cm STANDARD_DEVIATION 8.459 • n=4 Participants	161.00 cm STANDARD_DEVIATION 4.143 • n=4 Participants	169.75 cm STANDARD_DEVIATION 4.345 • n=6 Participants	167.75 cm STANDARD_DEVIATION 5.174 • n=6 Participants	164.17 cm STANDARD_DEVIATION 9.042 • n=6 Participants	169.58 cm STANDARD_DEVIATION 7.651 • n=6 Participants	170.08 cm STANDARD_DEVIATION 7.493 • n=6 Participants	164.33 cm STANDARD_DEVIATION 11.165 • n=6 Participants	168.68 cm STANDARD_DEVIATION 10.034 • n=12 Participants	172.42 cm STANDARD_DEVIATION 10.047 • n=6 Participants	168.05 cm STANDARD_DEVIATION 8.212 • n=66 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=12 Participants	0 Participants n=6 Participants	11 Participants n=66 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	9 Participants n=12 Participants	6 Participants n=6 Participants	55 Participants n=66 Participants
baseline weight	69.58 kg STANDARD_DEVIATION 7.027 • n=4 Participants	63.10 kg STANDARD_DEVIATION 7.935 • n=4 Participants	58.15 kg STANDARD_DEVIATION 4.692 • n=4 Participants	67.05 kg STANDARD_DEVIATION 6.961 • n=6 Participants	62.78 kg STANDARD_DEVIATION 6.635 • n=6 Participants	59.68 kg STANDARD_DEVIATION 9.639 • n=6 Participants	64.08 kg STANDARD_DEVIATION 7.362 • n=6 Participants	63.48 kg STANDARD_DEVIATION 5.553 • n=6 Participants	61.30 kg STANDARD_DEVIATION 7.266 • n=6 Participants	63.62 kg STANDARD_DEVIATION 7.793 • n=12 Participants	72.08 kg STANDARD_DEVIATION 11.152 • n=6 Participants	64.08 kg STANDARD_DEVIATION 8.028 • n=66 Participants
Race (NIH/OMB) White	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants	6 Participants n=6 Participants	66 Participants n=66 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Asian	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants	6 Participants n=6 Participants	66 Participants n=66 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants

PRIMARY outcome

Timeframe: from first dose until end of follow-up, up to 17 days

Outcome measures

Outcome measures
Measure	Cohort 4 (SAD - 20 mg) n=6 Participants 6 subjects in this cohort will receive a single dose of IPG11406 20 mg qd and 2 subjects will receive a single dose of placebo 20 mg qd orally.	Cohort 5 (SAD - 40 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 40 mg qd orally.	Cohort 6 (SAD - 80 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 80 mg qd orally.	Cohort 7 (MAD - 10 mg) n=6 Participants 6 subjects receive a dose of IPG11406 10 mg qd orally from Day 1 to 10-day.	Cohort 8 (MAD - 20 mg) n=6 Participants 6 subjects receive a dose of IPG11406 20 mg BID orally from Day 1 to 10-day.	Cohort 9 (MAD - 40 mg) n=6 Participants 6 subjects receive a dose of IPG11406 40 mg qd orally from Day 1 to 10-day.	Cohort 1 (SAD - 0.5 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 0.5 mg qd orally.	Cohort 2 (SAD - 2 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 2 mg qd orally.	Cohort 3 (SAD - 6 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 6 mg qd orally.	Placebo（SAD） n=6 Participants Total subjects in cohort SAD receive a single dose of placebo 0.5 mg,2 mg,6 mg,20 mg,40 mg,80 mg qd orally，respectively. 2 subjects per each dose.	Placebo（MAD） n=6 Participants Total subjects in cohort MAD receive a dose of placebo 10 mg qd, 20 mg bid, 40 mg qd orally from Day 1 to 10-Day, respectivelly. 2 subjects per each dose.
Safety Indicators：Adverse Event adverse events	3 Participants	4 Participants	5 Participants	4 Participants	6 Participants	5 Participants	1 Participants	3 Participants	2 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 10 days

Population: Cohorts 1-6 are Single Ascending Dose (SAD) cohorts, which only received a single dose on Day 1. No multiple administrations were conducted for these SAD cohorts, and thus no PK sampling or analysis was performed on Day 10. Consequently, the number of participants analyzed for Cohorts 1-6 on Day 10 is 0, which differs from the overall number of participants enrolled in these cohorts. Cohorts 7-9 are Multiple Ascending Dose (MAD) cohorts, which received multiple administrations and had PK analy

Peak concentration. It is directly obtained from the actual measured data of blood drug concentration-time. Steady-state maximum plasma concentration. Obtained directly from the measured plasma concentration-time data. Cohort1-Cohort6:Day 1, 6 hours before administration (within 1 hour); after administration, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours Cohort7-Cohort9:Day 1: Before administration (within 1 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24 hours after administration. Day 4, Day 6, Day 8: Before administration (within 1 hour before administration). Day 10: Before administration (within 1 hour before administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours after administration.

Outcome measures

Outcome measures
Measure	Cohort 4 (SAD - 20 mg) n=6 Participants 6 subjects in this cohort will receive a single dose of IPG11406 20 mg qd and 2 subjects will receive a single dose of placebo 20 mg qd orally.	Cohort 5 (SAD - 40 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 40 mg qd orally.	Cohort 6 (SAD - 80 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 80 mg qd orally.	Cohort 7 (MAD - 10 mg) n=6 Participants 6 subjects receive a dose of IPG11406 10 mg qd orally from Day 1 to 10-day.	Cohort 8 (MAD - 20 mg) n=6 Participants 6 subjects receive a dose of IPG11406 20 mg BID orally from Day 1 to 10-day.	Cohort 9 (MAD - 40 mg) n=6 Participants 6 subjects receive a dose of IPG11406 40 mg qd orally from Day 1 to 10-day.	Cohort 1 (SAD - 0.5 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 0.5 mg qd orally.	Cohort 2 (SAD - 2 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 2 mg qd orally.	Cohort 3 (SAD - 6 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 6 mg qd orally.	Placebo（SAD） Total subjects in cohort SAD receive a single dose of placebo 0.5 mg,2 mg,6 mg,20 mg,40 mg,80 mg qd orally，respectively. 2 subjects per each dose.	Placebo（MAD） Total subjects in cohort MAD receive a dose of placebo 10 mg qd, 20 mg bid, 40 mg qd orally from Day 1 to 10-Day, respectivelly. 2 subjects per each dose.
Pharmacokinetic Indicators: Maximum Plasma Concentration (Cmax) The Cmax data of the SAD group and the single-dose administration (D1) of the MAD group	271.48 ng/mL Standard Deviation 107.191	559.09 ng/mL Standard Deviation 131.992	1100.48 ng/mL Standard Deviation 506.708	141.76 ng/mL Standard Deviation 48.814	245.97 ng/mL Standard Deviation 44.820	552.85 ng/mL Standard Deviation 194.225	6.18 ng/mL Standard Deviation 1.812	27.31 ng/mL Standard Deviation 7.695	67.32 ng/mL Standard Deviation 23.190	—	—
Pharmacokinetic Indicators: Maximum Plasma Concentration (Cmax) The Cmax data of the MAD group after multiple administrations (D10)	—	—	—	164.79 ng/mL Standard Deviation 66.293	284.4 ng/mL Standard Deviation 61.490	573.69 ng/mL Standard Deviation 168.739	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 10 days

Population: Cohorts 1-6 are Single Ascending Dose (SAD) cohorts, which only received a single dose on Day 1. No multiple administrations were conducted for these SAD cohorts, and thus no PK sampling or AUC analysis was performed on Day 10. Consequently, the number of participants analyzed for Cohorts 1-6 on Day 10 is 0, which differs from the overall number of participants enrolled in these cohorts. Cohorts 7-9 are Multiple Ascending Dose (MAD) cohorts, which received multiple administrations and had PK A

From the last administration to the area under the blood concentration-time curve of the last measurable concentration. Calculated using the linear trapezoidal method: AUC(i, i+1) = (Ti+1 - Ti)(Ci + Ci+1) / 2, AUC0-t is the sum of all AUC(i, i+1). Cohort1-Cohort6:Day 1, 6 hours before administration (within 1 hour); after administration, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours Cohort7-Cohort9:Day 1: Before administration (within 1 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24 hours after administration. Day 4, Day 6, Day 8: Before administration (within 1 hour before administration). Day 10: Before administration (within 1 hour before administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours after administration.

Outcome measures

Outcome measures
Measure	Cohort 4 (SAD - 20 mg) n=6 Participants 6 subjects in this cohort will receive a single dose of IPG11406 20 mg qd and 2 subjects will receive a single dose of placebo 20 mg qd orally.	Cohort 5 (SAD - 40 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 40 mg qd orally.	Cohort 6 (SAD - 80 mg) n=6 Participants 6 subjects receive a single dose of IPG11406 80 mg qd orally.	Cohort 7 (MAD - 10 mg) n=6 Participants 6 subjects receive a dose of IPG11406 10 mg qd orally from Day 1 to 10-day.	Cohort 8 (MAD - 20 mg) n=6 Participants 6 subjects receive a dose of IPG11406 20 mg BID orally from Day 1 to 10-day.	Cohort 9 (MAD - 40 mg) n=6 Participants 6 subjects receive a dose of IPG11406 40 mg qd orally from Day 1 to 10-day.	Cohort 1 (SAD - 0.5 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 0.5 mg qd orally.	Cohort 2 (SAD - 2 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 2 mg qd orally.	Cohort 3 (SAD - 6 mg) n=4 Participants 4 subjects receive a single dose of IPG11406 6 mg qd orally.	Placebo（SAD） Total subjects in cohort SAD receive a single dose of placebo 0.5 mg,2 mg,6 mg,20 mg,40 mg,80 mg qd orally，respectively. 2 subjects per each dose.	Placebo（MAD） Total subjects in cohort MAD receive a dose of placebo 10 mg qd, 20 mg bid, 40 mg qd orally from Day 1 to 10-Day, respectivelly. 2 subjects per each dose.
Pharmacokinetic Indicators: Area Under the Plasma Concentration Versus Time Curve (AUC) The AUC data of the SAD group and the single-dose administration (D1) of the MAD group	1353.59 h*ng/mL Standard Deviation 876.624	6609.03 h*ng/mL Standard Deviation 2892.938	11104.87 h*ng/mL Standard Deviation 7518.955	683.93 h*ng/mL Standard Deviation 357.850	752.81 h*ng/mL Standard Deviation 132.739	2736.13 h*ng/mL Standard Deviation 1397.644	25.16 h*ng/mL Standard Deviation 15.438	162.03 h*ng/mL Standard Deviation 70.235	569.74 h*ng/mL Standard Deviation 504.435	—	—
Pharmacokinetic Indicators: Area Under the Plasma Concentration Versus Time Curve (AUC) The AUC data of the MAD group after multiple administrations (D10)	—	—	—	1627.45 h*ng/mL Standard Deviation 1274.247	993.57 h*ng/mL Standard Deviation 253.381	5321.30 h*ng/mL Standard Deviation 5011.186	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 10 days

Population: Cohorts 1-6 are Single Ascending Dose (SAD) cohorts, which received only a single dose on Day 1. No multiple administrations were conducted for these SAD cohorts, and thus no PK sampling or Tmax (Time to Maximum Concentration) analysis was performed on Day 10. Consequently, the number of participants analyzed for Cohorts 1-6 on Day 10 is 0, which differs from the overall number of participants enrolled in these cohorts. Cohorts 7-9 are Multiple Ascending Dose (MAD) cohorts, which received mult

Steady-state time to Cmax. Obtained directly from the measured plasma concentration-time data. Defined as the time of the first occurrence of Cmin, ss (when there are multiple maximum plasma concentrations), unless otherwise specified