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RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

NCT07371455•Longwood Pharmaceuticals (Hangzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo-controlled clinical trial featuring both single ascending dose (SAD), food effect and multiple ascending dose (MAD) phases intended to evaluate the safety, tolerability, PK, PD, and active metabolites of LWP779 after oral administration in healthy participants.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1\. Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent;
•2\. Males and females aged 18 to 65 years old (inclusive) at the time of signing the ICF.
•3.No history of past or current diseases or abnormalities involving the cardiac, hepatic, renal, gastrointestinal, nervous, respiratory, or ocular systems, as well as psychiatric or metabolic abnormalities, that are clinically significant as judged by the investigator.
•4.Participants must be confirmed healthy through medical history, VS, physical examination, clinical laboratory tests , and a 12-lead ECG;
•5\. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg at the time of screening and Day -1.
•6\. Participants must agree to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
•7.Normal renal function (defined as eGFR ≥ 80 mL/min/1.73 m2) at screening and Day -1.
•8\. Ability to swallow and retain oral medication.
•9.No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or Day -1.

Exclusion Criteria

•1.Known hypersensitivity to LWP779 or any of its constituents.
•2.Known or suspected tumor.
•3.History of unexplained syncope, symptomatic hypotension or hypoglycemia.
•4.Presence of orthostatic hypotension at screening or Day -1.
•5.Participants with any ocular diseases (e.g., glaucoma, fundus macular degeneration, corneal lesions, retinopathy, etc.).
•6.Family history of long QTc syndrome; mean QTcF interval \>450 msec for males and \>470 msec for females or presence of any other mean ECG abnormality at screening or Day -1 deemed clinically significant by the PI/medical delegate.
•7.Resting pulse rate \<45 bpm or \>100 bpm at screening, or Day -1.
•8.Systolic blood pressure \< 90 or \>160 mm Hg and/or diastolic blood pressure \< 50 or \> 95 mm Hg at screening or Day -1.
•9.History of unstable ischemic heart disease, recent (within 6 months of screening) myocardial infarction, or presence of clinically significant cardiac arrhythmia.
•10.Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as ALT, AST, gamma glutamyl transferase (GGT), alkaline phosphatase (ALP) or total/direct bilirubin \> 1.5x ULN at screening or Day -1. Participants with confirmed Gilbert's syndrome will not be permitted to enroll in the study.
+23 more criteria

Locations (1)

CMAX Clinical Research Pty Ltd

Adelaide, Australia

Key Dates

Start Date

March 13, 2026

Primary Completion Date

July 10, 2026

Completion Date

September 30, 2026

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Ischemic Stroke

Interventions

LWP779

DRUG

Placebo of LWP779

DRUG

Contacts

Tingting Yan

CONTACT

+86 15989276332 tingting.yan1@longwoodtech.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Inclusion Criteria

Exclusion Criteria

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