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OpenTrials
Completed

NCT Number: NCT07546149

A Multiple Ascending Dose Study of LW402 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.

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Key information

Conditions

Safety Evaluation of Escalating Doses

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shangdong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Drug

LW402 Tablets

Placebo

Drug

LW402 Placebo Tablets

Primary outcomes

  1. Safety and Tolerability Assessment

    Time frame: up to 9 days

    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.

Secondary outcomes

  1. Evaluate the PK characteristics

    Time frame: up to 9 days

    Measuring the level of LW402 and its primary metabolite in the blood.

Sponsors and collaborators

Lead sponsor

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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