Ischemic StrokePhase 1NCT07371455
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants
A Phase 1 study testing LWP779 in people with Ischemic Stroke, run by Longwood Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- LWP779
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Mar 2026to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 11.History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance deemed clinically significant by the PI/medical delegate.
- 12.History of cerebral hemorrhage (e.g., post-traffic accident), stroke, or cerebrovascular disease.
- 13.Participants judged by the PI/medical delegate to have any condition or history that may alter or increase bleeding tendency.
- 14.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.
- 15.Participants with conditions that may, in the opinion of the PI/medical delegate, significantly affect normal venous blood collection.
- 16.Positive results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening.
- 17.Donated or lost >500 ml of blood in the previous 3 months prior to screening, donation of bone marrow or peripheral stem cells within 90 days prior to Day 1, or donation of plasma within 30 days prior to Day 1.
- 18.Participants who have participated in any investigational drug study within the past 3 months or 5 half-lives (whichever is longer) prior to dosing, or have participated in any investigational device study within the past 3 months prior to dosing.
- 19.Previous exposure to LWP779.
- 20.Use of prescription medications, vaccination, or any drugs known to induce or inhibit CYP3A4/5 or P-glycoprotein within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- 21.Use of over-the-counter (OTC) medication or supplements (including vitamins, dietary supplements, herbal medicines, homoeopathy, etc.) within 14 days or 5 half-lives (whichever is longer), prior to receiving the first dose of study drug that might have impact on the clinical trial as per the PI/medical delegate's discretion. Acetaminophen (paracetamol) is permitted if provided maximum daily dose does not exceed 2000 mg.
- 22.Hospital admission or major surgery within 6 months prior to screening, or history of bariatric surgery.
- 23.A history of prescription drug misuse (as assessed by the PI/medical delegate), or positive urine drug screen at screening or Day -1.
- 24.Regular consumption of more than 10 standard alcoholic drinks per week or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
- 25.Consumes more than 2 cigarettes or equivalent nicotine-containing products per week, and/or is unwilling to abstain from the use of such products for 7 days prior to Day -1 through to EOS. Positive cotinine test at Day -1.
- 26.Use of cannabis or cannabidiol (CBD) containing products, in any form (e.g., edibles, oil, lotion, smoking) within 30 days prior to study drug administration on Day 1, regardless of legality within a given State, County or Region.
- 27.Participant is pregnant (as determined by pregnancy test result at screening or Day -1) or breastfeeding.
- 28.Participants who had consumed any food or beverage containing caffeine, alcohol, xanthine, Seville orange, pomelo, dragon fruit, starfruit, guava or grapefruit within 48 hours before each admission to the CRU.
- 29.A positive screen for alcohol at screening or Day -1.
- 30.Employee or family member of the Investigator (PI/medical delegate), study site personnel, or sponsor.
- 31.Food Effect study part only: unwilling to consume a high-fat meal consisting of eggs, bacon, butter, white bread and full cream milk.
- 32.Unable or unwilling to comply with the study restrictions and requirements
- 33.Participant developed an acute condition during the screening phase or before administration of the study drug; any other condition or finding that in the PI/medical delegate's opinion would put the participant or study conduct at risk if the participant were to be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research Pty Ltd
Adelaide
About this study
Official title: 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
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
- Being tested
- LWP779, Placebo of LWP779
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LWP779Drug
Active
Placebo of LWP779Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose - 150 mg | Experimental | Not described Receives: Drug: LWP779; Drug: Placebo of LWP779 |
| Single Ascending Dose - 300 mg | Experimental | Not described Receives: Drug: LWP779; Drug: Placebo of LWP779 |
| Single Ascending Dose - 600 mg | Experimental | Not described Receives: Drug: LWP779; Drug: Placebo of LWP779 |
| Single Ascending Dose - 900 mg | Experimental | Not described Receives: Drug: LWP779; Drug: Placebo of LWP779 |
| Single Ascending Dose - 1200 mg | Experimental | Not described Receives: Drug: LWP779; Drug: Placebo of LWP779 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants with a treatment-emergent adverse event (TEAE)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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）
Measured: Wthin 30 minutes before administration and to 24 hours after administration.
Maximum concentration (Cmax) of LWP779 and its active metabolites in plasma
Measured: Within 30 minutes before administration to 48 hours after single administration
Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma
Measured: 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
Measured: 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
Measured: Within 30 minutes before administration to 48 hours after single administration
Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma
Measured: Within 30 minutes before administration to 48 hours after single administration
Apparent clearance (CL/F) of LWP779 and its active metabolites in plasma
Measured: Within 30 minutes before administration to 48 hours after single administration
Apparent volume of distribution divided by bioavailability (Vd/F) of LWP779 and its active metabolites in plasma
Measured: Within 30 minutes before administration to 48 hours after single administration
Lag time (tlag) of LWP779 and its active metabolites in plasma
Measured: Within 30 minutes before administration to 48 hours after single administration
Steady-state minimum concentration (Cmin,ss) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Steady-state maximum concentration (Cmax,ss) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Steady-state average concentration (Cavg,ss) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Area under the concentration-time curve from time zero to tau (AUC0-τ) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Accumulation index (AUC0-τ (D7) / AUC0-τ (D1)) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Cmax (D7) / Cmax (D1)) of LWP779 and its active metabolites in plasma
Measured: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start13 Mar 2026
- Primary completion10 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longwood Pharmaceuticals (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371455
- Sponsor's protocol ID
- LW-A001
- Status last verified
- Mar 2026
- First submitted
- 25 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07371455
- Acronym / sponsor ID
- LW-A001
- Conditions
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Longwood Pharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LWP779Active | Drug | 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 LWP779Placebo | Drug | 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 |
Primary outcome
Number and proportion of participants with a treatment-emergent adverse event (TEAE)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
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.
Number of participants with abnormal laboratory tests results
Time frame: 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
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
18 secondary outcomes
C-QTc in the dose escalation part of SAD（in the dose groups of ≥300 mg）
Time frame: Wthin 30 minutes before administration and to 24 hours after administration.
Maximum concentration (Cmax) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma
Time frame: 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
Time frame: 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
Time frame: Within 30 minutes before administration to 48 hours after single administration
Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Apparent clearance (CL/F) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Apparent volume of distribution divided by bioavailability (Vd/F) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Lag time (tlag) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Steady-state minimum concentration (Cmin,ss) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Steady-state maximum concentration (Cmax,ss) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Steady-state average concentration (Cavg,ss) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Area under the concentration-time curve from time zero to tau (AUC0-τ) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Accumulation index (AUC0-τ (D7) / AUC0-τ (D1)) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Cmax (D7) / Cmax (D1)) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LWP779 in people with Ischemic Stroke, run by Longwood Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingting Yan (+86 15989276332, tingting.yan1@longwoodtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of participants with a treatment-emergent adverse event (TEAE) (time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.