Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants
Led by Longwood Pharmaceuticals (Hangzhou) Co., Ltd. · Updated on 2026-03-20
76
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Male or female aged 18 to 65 years
- No significant past or current diseases in major organ systems or psychiatric/metabolic conditions
- Confirmed healthy by medical history, vital signs, physical exam, lab tests, and ECG
- Body mass index between 18.0 and 32.0 kg/m2 and body weight at least 50 kg
- Agree to use approved effective contraception during the trial
- Normal kidney function (eGFR ≥ 80 mL/min/1.73 m2) at screening and Day -1
- Able to swallow and keep oral medication
- No suicidal thoughts shown by a score of 0 on the Columbia Suicide Severity Rating Scale at screening or Day -1
You will not qualify if you...
- Known allergy to LWP779 or its ingredients
- Known or suspected tumors
- History of unexplained fainting, symptomatic low blood pressure, or low blood sugar
- Orthostatic hypotension at screening or Day -1
- Any eye diseases like glaucoma, macular degeneration, corneal lesions, or retinopathy
- Family history of long QTc syndrome or abnormal ECG readings deemed significant
- Resting heart rate below 45 bpm or above 100 bpm at screening or Day -1
- Blood pressure outside of 90-160 mm Hg systolic or 50-95 mm Hg diastolic at screening or Day -1
- History of unstable heart disease, recent heart attack (within 6 months), or significant heart rhythm problems
- Liver disease or abnormal liver tests above 1.5 times normal limits at screening or Day -1
- History of chronic diarrhea, malabsorption, unexplained weight loss, or significant food allergies
- History of brain bleeding, stroke, or cerebrovascular disease
- Conditions or history that increase bleeding risk
- Use of blood-thinning drugs within 3 months before screening
- Conditions affecting normal blood collection
- Positive tests for HIV, hepatitis B, or hepatitis C at screening
- Blood donation or loss over 500 ml in past 3 months or recent bone marrow/plasma donation
- Participation in other investigational drug or device studies within 3 months prior to dosing
- Prior exposure to LWP779
- Use of prescription or over-the-counter drugs affecting certain liver enzymes or drug transporters within specified timeframes
- Hospital admission or major surgery within 6 months prior to screening
- History of prescription drug misuse or positive drug screen
- Regular consumption of more than 10 alcoholic drinks per week or more than 4 drinks on any day
- Use of more than 2 cigarettes or nicotine products per week and unwillingness to abstain during the study
- Use of cannabis or cannabidiol products within 30 days before dosing
- Pregnancy or breastfeeding
- Consumption of caffeine, alcohol, or certain fruits within 48 hours before clinical admission
- Positive alcohol screen at screening or Day -1
- Investigator or study staff or family member involvement
- Unwillingness to consume a high-fat meal for the Food Effect study part
- Unable or unwilling to follow study restrictions and requirements
- Development of acute conditions during screening or before dosing that pose risk to participant or study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research Pty Ltd
Adelaide, Australia
Actively Recruiting
Research Team
T
Tingting Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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