NCT06490263

the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids in Human

A Phase I Clinical Trial in Healthy and Overweight/Obese Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Beijing Wehand-Bio Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy ，overweight and obesity subjects.

Detailed description

This is a Phase I clinical trial of safety, tolerability and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy and overweight or obesity subjects. This trial is divided into three parts: The first part study aims to compare the pharmacokinetics characteristics of WH006 chewing with the first bite of a standardized meal or swallowing after a standardized meal in healthy subjects. The second part study aims to investigate the safety, tolerability and pharmacokinetics of single ascending doses of WH006 in healthy subjects. The third part study aims to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of WH006 in both healthy participants and overweight or obese subjects.

Conditions

• Overweight and Obesity
• Healthy

Interventions

Type	Name	Description
DRUG	Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects	Part One: Administered by chewing with meals or swallowing after meals, with a dosage of 126 milligrams, given as a single dose only.
DRUG	Mulberry Twig Alkaloids Tablets with single dose in healthy subjects	Parts Two: Administered by swallowing after meals with four distinct dosage groups.
DRUG	Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects	Part Three: Administered by swallowing after meals with two distinct dosage groups, taken three times daily.
DRUG	Mulberry Twig Alkaloids Tablets with multiple dose in overweight or obese subjects	Part Three: Administered by swallowing after meals with two distinct dosage groups, taken three times daily.

Timeline

• Start date: 2024-05-13
• Primary completion: 2024-10-19
• Completion: 2024-11-04
• First posted: 2024-07-08
• Last updated: 2026-01-20

Locations

1 site across 1 country: China