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COMPLETED
NCT07801326
PHASE1

A Study to Evaluate Different Administration Conditions and the Food Effect of MWN109 Tablets in Chinese Participants

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, multiple-dose study to evaluate the effects of different volumes of administration water, post-dose fasting duration, and high-fat diet on the pharmacokinetics of the 15 mg dose of MWN109 tablets in adult Chinese participants, as well as to assess its safety, tolerability, and immunogenicity. The study consists of two parts. Part 1 is an administration condition study, which includes 6 groups stratified by post-dose fasting duration and administration water volume. Part 2 is a food-effect study, comprising 3 groups stratified by dietary conditions.. A total of 162 participants are planned to be enrolled. The primary endpoint is pharmacokinetics (PK). PK parameters include Cmax, Cmin, AUC0-t, AUC0-∞, Tmax, and t1/2. Secondary endpoints include safety (adverse events \[AEs\] and serious adverse events \[SAEs\]) and immunogenicity (anti-drug antibodies \[ADAs\]).

Official title: A Randomized, Open-Label Study to Evaluate the Effects of Different Dosing Conditions and Post-Dose Meal Timing on the Pharmacokinetics of MWN109 Tablets in Chinese Adult Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2026-05-24

Completion Date

2026-08-10

Last Updated

2026-09-03

Healthy Volunteers

Yes

Interventions

DRUG

MWN109 Tablets

administered orally

Locations (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, China