At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating IPG11406 for Inflammatory Bowel Diseases. Completed, enrolled 66 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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