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Phase 1 Study for IPG11406 in Health Volunteer

NCT06255834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-17

Study results available
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Summary

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 IPG11406 in healthy adult participants

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

IPG11406

IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 \~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets

Sponsors & Collaborators

  • Zhejiang Hospital

    collaborator OTHER

  • Nanjing Immunophage Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-24
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06255834 on ClinicalTrials.gov