HMPL004-6599 Phase I Dose-escalating Study

Ulcerative Colitis Clinical Trial

Official title: A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers

Status Terminated

Clinical Trial Summary

To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers

Clinical Trial Description

This is a Phase I study with two parts:

Part A: Double blind, randomized, placebo-controlled, dose-escalating, single dose study in healthy volunteers.

Subjects will receive a single dose of up to 1800 mg HMPL004-6599 or matching placebo on Day

1. The planned dose levels are: 600, 1200, and 1800 mg under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).

Part B: Double blind, randomized, placebo-controlled, dose-escalating, multiple dose study in healthy male volunteers.

Dose levels in Part B for 14 days are planned as 200mg TID, 400mg TID, 600mg BID and 600mg TID. These dose were jointly decided by the PI, SMC and the Sponsor based on the results from Part A. On day 14, only one dose in the morning will be administrated for all cohorts. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).

In Part A, cohort 1 will consist of a blinded sentinel group of two subjects; one subject will receive HMPL004-6599 and the other will receive placebo, at least 24 hours prior to dosing the remaining 6 subjects in the cohort. The remaining subjects will only be dosed after review of available safety data from the sentinel subjects.

During Part A and Part B, PK sample collections will take place. During Part A, a full PK profile will be measured throughout Day 1. Samples will be collected from pre-dose to 24 hours post dose.

Part B PK sample collection is based on Part A study data. A full PK testing of plasma samples from pre-dose to 8 (TID) or 12 (BID) hours post dose will be collected on the first and last dosing days. Stool samples produced at baseline before dose and day 14-15 post last dose will be collected.

Concentrations of Andrographolide (AND), 14-deoxy-11,12- didehydroandrographolide (DDAND), HM5013620, neoandrographolide (NAND) and 14-deoxyandrographolide (DAND) in plasma (Part A and B) and fecal samples (Part B) will be determined for each dose level.

The plasma samples will be analyzed at the lab contracted by the Sponsor. ;

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Ulcerative Colitis

• NCT number: NCT03597971
• Study type: Interventional
• Source: Nutrition Science Partners Limited
• Status: Terminated
• Phase: Phase 1
• Start date: March 20, 2018
• Completion date: November 19, 2018