NCT05288543

A Study of Orally Administered IPG7236 in Healthy Adult Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Food Effect of Orally Administered IPG7236 in Healthy Adult Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Nanjing Immunophage Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	IPG7236- Single ascending dose	Subjects will receive IPG7236 tablets orally once on Day 1 in a fasted state
DRUG	IPG7236- Multiple ascending dose	Subjects will receive IPG7236 tablets orally once daily for 10 days from Day1 to Day 10 in a fasted state
OTHER	Placebo (Part A)	Subjects will receive IPG7236 tablets orally once on Day 1 (Part A) or once daily for 10 days from Day1 to Day 10 (Part B) in a fasted state

Timeline

• Start date: 2022-04-07
• Primary completion: 2023-03-31
• Completion: 2025-11-26
• First posted: 2022-03-21
• Last updated: 2025-12-22

Locations

1 site across 1 country: Australia