the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids in Human
NCT06490263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-01-20
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.
Conditions
- Overweight and Obesity
- Healthy
Interventions
- 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.
Sponsors & Collaborators
-
Peking University First Hospital
collaborator OTHER -
Beijing Wehand-Bio Pharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Ying Gao, MD · Peking University First Hospital
-
Xia Zhao, Master · Peking University First Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-13
- Primary Completion
- 2024-10-19
- Completion
- 2024-11-04
Countries
- China
Study Locations
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