CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 76 enrolled
Drug / intervention
IPG1094 300 mg SAD +9 moredrug
Likely dose
IPG1094 300 mg SADfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05112159
NCT05112159Phase 1Completed
CompareCT.gov

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered IPG1094 in Healthy Adult Participants

Nanjing Immunophage Biotech Co., Ltd·interventional·Posted Nov 8, 2021·Updated May 1, 2026

In Brief

A Phase 1 clinical trial evaluating IPG1094 300 mg SAD, IPG1094 600 mg SAD, and 8 other interventions for Healthy Volunteers. Completed, enrolled 76 participants across 1 site.

Detailed Summary

This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of single dose orally administered IPG1094 in healthy adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesAustralia
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 8, 2021
Enrollment StartSep 27, 2021
Primary CompletionJul 25, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.6 years ago

Interventions

IPG1094 300 mg SADdrug

a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets

IPG1094 600 mg SADdrug

A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets

IPG1094 900 mg SADdrug

A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets

IPG1094 1200 mg SADdrug

A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets

IPG1094 600 mg MAD QDdrug

Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.

IPG1094 200 mg MAD BIDdrug

Dosing starts on Day 1 and extends over a 10-day period. Subjects are discharged on Day 13, with a follow-up 7 days after the last dose, each cohort comprises approximately eight subjects, with 6 subjects on IPG1094 and 2 subjects on placebo

IPG1094 300 mg MAD BIDdrug

Dosing starts on Day 1 and extends over a 10-day period. Subjects are discharged on Day 13, with a follow-up 7 days after the last dose, each cohort comprises approximately eight subjects, with 6 subjects on IPG1094 and 2 subjects on placebo

IPG1094 300 mg Fed-Fasteddrug

For Cohort FE-2, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fed condition, and Day 5 (anticipated) of Period 2 under fasted condition.

IPG1094 300 mg Fasted-Feddrug

For Cohort FE-1, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fasted condition, and Day 5 (anticipated) of Period 2 under the fed condition.

IPG1094 100 mg SADdrug

a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets