A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in… (NCT07371455) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants
Australia76 participantsStarted 2026-03-13
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Number and proportion of participants with a treatment-emergent adverse event (TEAE)
Timeframe: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
2
12-lead electrocardiogram (ECG) (QT Interval)
Timeframe: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
3
Number of participants with abnormal vital signs
Timeframe: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
4
Number of participants with abnormal physical examination findings
Timeframe: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
5
Columbia Suicide Severity Rating Scale (C-SSRS)
Timeframe: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
6
Number of participants with abnormal laboratory tests results
Timeframe: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
7
Number of participants with abnormal ophthalmoscopic-examination findings