A Multiple Ascending Dose Study of LW402 in Healthy Volunteers

NCT07546149 | Completed Phase 1

• 1 other identifier: LW402-I-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety Evaluation of Escalating Doses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the PK characteristics

  up to 9 days

Study Arms (6)

Dose 200mg

EXPERIMENTAL

LW402 200 mg, PO BID

Drug: Experimental

Dose 250mg

EXPERIMENTAL

LW402 250 mg, PO BID

Drug: Experimental

Dose 300mg

EXPERIMENTAL

LW402 300 mg, PO BID

Drug: Experimental

Placebo Dose 200mg

PLACEBO COMPARATOR

LW402 placebo tablets,200 mg, PO BID

Drug: Placebo

Placebo Dose 250mg

PLACEBO COMPARATOR

LW402 Placebo Tablets,250 mg, PO BID

Drug: Placebo

Placebo Dose 300mg

PLACEBO COMPARATOR

LW402 Placebo Tablets,300mg,BID

Drug: Placebo

Interventions

Experimental DRUG

LW402 Tablets

Dose 200mg; Dose 250mg; Dose 300mg

Placebo DRUG

LW402 Placebo Tablets

Placebo Dose 200mg; Placebo Dose 250mg; Placebo Dose 300mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Longwood Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shangdong, China

Location

Study Officials

• Wei Zhao

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: April 22, 2026
• Study Start: October 15, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 31, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)