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

NCT07371455 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LW-A001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (7)

• Number and proportion of participants with a treatment-emergent adverse event (TEAE)

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

• 12-lead electrocardiogram (ECG) (QT Interval)

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

• Number of participants with abnormal vital signs

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

• Number of participants with abnormal physical examination findings

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

• Columbia Suicide Severity Rating Scale (C-SSRS)

  The Columbia Suicide Severity Rating Scale (C-SSRS) is used to assess suicidal ideation and suicidal behavior. Within the module "Answer for Actual Suicidal Attempts Only", the scoring range is 0 to 5. A score of 0 indicates no physical damage or very minor physical damage (e.g. surface scratches), and a score of 5 indicates death.

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

• Number of participants with abnormal laboratory tests results

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

• Number of participants with abnormal ophthalmoscopic-examination findings

  From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD

Secondary Outcomes (18)

• C-QTc in the dose escalation part of SAD（in the dose groups of ≥300 mg）

  Wthin 30 minutes before administration and to 24 hours after administration.

• Maximum concentration (Cmax) of LWP779 and its active metabolites in plasma

  Within 30 minutes before administration to 48 hours after single administration

• Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma

  Within 30 minutes before administration to 48 hours after single administration

• Total area under the concentration time curve (AUC) of LWP779 and its active metabolites in plasma

  Within 30 minutes before administration to 48 hours after single administration

• Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma

  Within 30 minutes before administration to 48 hours after single administration

Study Arms (5)

Single Ascending Dose - 150 mg

EXPERIMENTAL

Drug: LWP779; Drug: Placebo of LWP779

Single Ascending Dose - 300 mg

EXPERIMENTAL

Drug: LWP779; Drug: Placebo of LWP779

Single Ascending Dose - 600 mg

EXPERIMENTAL

Drug: LWP779; Drug: Placebo of LWP779

Single Ascending Dose - 900 mg

EXPERIMENTAL

Drug: LWP779; Drug: Placebo of LWP779

Single Ascending Dose - 1200 mg

EXPERIMENTAL

Drug: LWP779; Drug: Placebo of LWP779

Interventions

LWP779 DRUG

Active

Single Ascending Dose - 1200 mg; Single Ascending Dose - 150 mg; Single Ascending Dose - 300 mg; Single Ascending Dose - 600 mg; Single Ascending Dose - 900 mg

Placebo of LWP779 DRUG

Placebo

Single Ascending Dose - 1200 mg; Single Ascending Dose - 150 mg; Single Ascending Dose - 300 mg; Single Ascending Dose - 600 mg; Single Ascending Dose - 900 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent;
• \. Males and females aged 18 to 65 years old (inclusive) at the time of signing the ICF.
• 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.
• Participants must be confirmed healthy through medical history, VS, physical examination, clinical laboratory tests , and a 12-lead ECG;
• \. 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.
• \. Participants must agree to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
• Normal renal function (defined as eGFR ≥ 80 mL/min/1.73 m2) at screening and Day -1.
• \. Ability to swallow and retain oral medication.
• No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or Day -1.

You may not qualify if:

• Known hypersensitivity to LWP779 or any of its constituents.
• Known or suspected tumor.
• History of unexplained syncope, symptomatic hypotension or hypoglycemia.
• Presence of orthostatic hypotension at screening or Day -1.
• Participants with any ocular diseases (e.g., glaucoma, fundus macular degeneration, corneal lesions, retinopathy, etc.).
• 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.
• Resting pulse rate \<45 bpm or \>100 bpm at screening, or Day -1.
• Systolic blood pressure \< 90 or \>160 mm Hg and/or diastolic blood pressure \< 50 or \> 95 mm Hg at screening or Day -1.
• History of unstable ischemic heart disease, recent (within 6 months of screening) myocardial infarction, or presence of clinically significant cardiac arrhythmia.
• 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.
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance deemed clinically significant by the PI/medical delegate.
• History of cerebral hemorrhage (e.g., post-traffic accident), stroke, or cerebrovascular disease.
• Participants judged by the PI/medical delegate to have any condition or history that may alter or increase bleeding tendency.
• Participants regularly using drugs affecting coagulation function within 3 months before screening, or had received anticoagulant therapy such as heparin, low-molecular-weight heparin, fibrinolytic agents, etc. in the same timeframe.
• Participants with conditions that may, in the opinion of the PI/medical delegate, significantly affect normal venous blood collection.

Sponsors & Collaborators

• Longwood Pharmaceuticals (Hangzhou) Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, Australia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Tingting Yan

CONTACT

+86 15989276332; tingting.yan1@longwoodtech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 28, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

AU (1)