A Study of Orally Administered IPG7236 in Healthy Adult Participants

Status Not yet recruiting

Clinical Trial Summary

The study is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic and food effect of orally administered IPG7236 in healthy adult participants.

Clinical Trial Description

The study consists of two parts Part A (Single ascending dose): There are total 8 Single Ascending Dose cohorts. Dose levels are as follows Cohort 1: 25 mg of IPG7236 or placebo as per the randomization code, Cohort 2: 50 mg of IPG7236 or placebo as per the randomization code Cohort 3: 100 mg of IPG7236 or placebo as per the randomization code Cohort 4: 200 mg of IPG7236 or placebo as per the randomization code Cohort 5: 300 mg of IPG7236 or placebo as per the randomization code Cohort 6: 400 mg of IPG7236 or placebo as per the randomization code Cohort 7: 500 mg of IPG7236 or placebo as per the randomization code Cohort 8: 600 mg of IPG7236 or placebo as per the randomization code In Cohort 1 total of 6 subjects enrolled. The 4 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code. In Cohort 2 to Cohort 8, 6 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code. Part B (Multiple ascending dose): There are total 3 Multiple ascending dose cohorts. Dose levels are as follows Cohort 1: 100 mg of IPG7236 or placebo as per the randomization code Cohort 2: 300 mg of IPG7236 or placebo as per the randomization code Cohort 3: 500 mg of IPG7236 or placebo as per the randomization code Total of 8 subjects per cohort, 6 subjects will receive IPG7236 and 2 subjects will receive placebo per the randomization code The Multiple Ascending Dose phase of Cohort 1, Cohort 2 and Cohort 3 will commence based on the safety and tolerability data obtained from Single Ascending Dose phase of Cohort 4, Cohort 6 and Cohort 8. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05288543
Study type	Interventional
Source	Nanjing Immunophage Biotech Co., Ltd
Contact	Daisy Zhu
Phone	21 34782827&
Email	xyzhu@immunophage.com.cn
Status	Not yet recruiting
Phase	Phase 1
Start date	April 11, 2022
Completion date	November 30, 2022

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