A Multiple Ascending Dose Study of LW402 in Healthy Volunteers

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LW402 Tablets Following Multiple Doses in Healthy Volunteers

This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability and pharmacokinetics of multiple doses of LW402 tablets in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Safety Evaluation of Escalating Doses
• Intervention / Treatment: Drug: Experimental; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shangdong
    • Jinan, Shangdong, China
      • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
• Body Mass Index of 18-26 kg/m2 inclusive with body weight males ≥ 50 kg, females ≥ 45 kg

Exclusion Criteria:

• Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
• History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
• Other exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 200mg; LW402 200 mg, PO BID	Drug: Experimental; LW402 Tablets
Experimental: Dose 250mg; LW402 250 mg, PO BID	Drug: Experimental; LW402 Tablets
Experimental: Dose 300mg; LW402 300 mg, PO BID	Drug: Experimental; LW402 Tablets
Placebo Comparator: Placebo Dose 200mg; LW402 placebo tablets,200 mg, PO BID	Drug: Placebo; LW402 Placebo Tablets
Placebo Comparator: Placebo Dose 250mg; LW402 Placebo Tablets,250 mg, PO BID	Drug: Placebo; LW402 Placebo Tablets
Placebo Comparator: Placebo Dose 300mg; LW402 Placebo Tablets,300mg,BID	Drug: Placebo; LW402 Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability Assessment	Safety and Tolerability Assessment: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), along with abnormal clinical laboratory parameters, vital signs, physical examination findings, and 12-lead electrocardiogram (ECG) results.	up to 9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the PK characteristics	Measuring the level of LW402 and its primary metabolite in the blood.	up to 9 days

Collaborators and Investigators

• Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Wei Zhao, Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LW402-I-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No