Actively Recruiting
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
Led by Longwood Pharmaceuticals (Hangzhou) Co., Ltd. · Updated on 2026-03-20
76
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and active metabolites of the drug LWP779 after oral administration in healthy adults. This Phase 1 study includes single ascending dose (SAD), food effect, and multiple ascending dose (MAD) phases to understand how the drug behaves in the body and its safety profile. The study involves administering LWP779 or a placebo to healthy participants in varying doses during different phases. The SAD phase tests increasing single doses, the food effect phase examines the impact of eating on drug absorption, and the MAD phase assesses multiple doses over time. Participants receive oral doses under controlled conditions, including a high-fat meal during the food effect phase, with careful monitoring throughout each phase. Participants will be involved in medical history reviews, physical exams, vital sign checks, laboratory tests, 12-lead ECGs, and suicide severity ratings to monitor safety from baseline through days 7 to 16 depending on the phase. Researchers will measure adverse events, vital sign changes, ECG results, and laboratory abnormalities to assess tolerability. The trial runs from screening through the treatment phases, with detailed pharmacokinetic sampling to track how LWP779 and its metabolites are processed in the body.
CONDITIONS
Brief 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
- Males and females aged 18 to 65 years at consent
- No significant past or current diseases in heart, liver, kidneys, digestive, nervous, lung, eye, psychiatric, or metabolic systems
- 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 weight at least 50 kg
- Agree to use effective contraception during the trial if applicable
- Normal kidney function (eGFR 280 mL/min/1.73 m2) at screening and Day -1
- Able to swallow and keep oral medication
- No suicidal thoughts as shown by a zero score on the Columbia Suicide Severity Rating Scale at screening or Day -1
You will not qualify if you...
- Allergic to LWP779 or its ingredients
- Known or suspected tumor
- History of unexplained fainting, low blood pressure symptoms, or low blood sugar
- Orthostatic hypotension at screening or Day -1
- Any eye diseases like glaucoma or retinopathy
- Family history of long QT syndrome or abnormal ECG readings
- Resting pulse below 45 or above 100 beats per minute
- Blood pressure outside 90-160 mm Hg systolic or 50-95 mm Hg diastolic
- History of unstable heart disease, recent heart attack, or serious arrhythmia
- Liver disease or abnormal liver tests beyond 1.5 times normal
- History of chronic diarrhea, malabsorption, or food allergies
- History of cerebral hemorrhage, stroke, or cerebrovascular disease
- Conditions increasing bleeding risk
- Recent use of blood thinners or anticoagulants
- Conditions affecting normal blood collection
- Positive tests for HIV, hepatitis B or C
- Significant blood donation or bone marrow donation recently
- Participation in other drug or device studies recently
- Previous exposure to LWP779
- Recent use of prescription drugs affecting metabolism enzymes
- Recent use of supplements or medications that could affect the trial except limited acetaminophen
- Recent major surgery or hospitalization
- History of prescription drug misuse or positive drug screen
- Regular heavy alcohol use
- Smoking more than 2 cigarettes or equivalent per week and unwilling to abstain
- Use of cannabis or related products within 30 days
- Pregnancy or breastfeeding
- Consumed caffeine, alcohol, or certain fruits within 48 hours before admission
- Positive alcohol screen at screening or Day -1
- Employment or family relation to study personnel
- In Food Effect part, unwillingness to eat a high-fat meal
- Unable or unwilling to follow study rules
- Acute illness during screening or before dosing that could increase risk or affect study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 days depending on dose group
Participants receive single or multiple ascending doses of the study drug or placebo and undergo safety, tolerability, and pharmacokinetic assessments.
Multiple visits including dosing and assessments over up to 16 days
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research Pty Ltd
Adelaide, Australia
Actively Recruiting
Research Team
T
Tingting Yan
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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