A Study of HL40626S Tablets in Healthy Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHighsLab Therapeutics Inc.
About this trial
This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.
Eligibility criteria
Qualifiers
Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening.
BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening, with a body weight ≥ 50 kg.
In good general health, as determined by the Investigator.
Disqualifiers
Clinically significant abnormal medical history, such as gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, drug hypersensitivity, as determined by the Investigator, any abnormal findings on physical examination, VS measurements, ECG or laboratory tests at Screening, Admission or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety.
Any out-of-range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator.
Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and/or complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities).
Participants with QTcF >450 msec (if male) or >470 msec (if female) will be excluded.
Trial design
Treatments tested in this trial
- HL40626S tablets
- HL40626S placebo
Treatment groups
64 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov