Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants

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.

Conditions

• Healthy Volunteers

Interventions

DRUG

IPG1094 100 mg SAD

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

DRUG

IPG1094 300 mg SAD

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

DRUG

IPG1094 600 mg SAD

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

DRUG

IPG1094 900 mg SAD

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

DRUG

IPG1094 1200 mg SAD

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

DRUG

IPG1094 600 mg MAD QD

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

DRUG

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

DRUG

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

DRUG

IPG1094 300 mg Fed-Fasted

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

DRUG

IPG1094 300 mg Fasted-Fed

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

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd

  lead INDUSTRY

Principal Investigators

• Christopher Argent · Scientia Clinical Research Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-27

Primary Completion

2022-07-25

Completion

2022-07-25

FDA Drug

Yes

Countries

• Australia

Study Locations