A Phase 1 interventional study of HL40626S tablets and HL40626S placebo in Psoriasis (PsO), Skin Disease and Immune System Disease, sponsored by HighsLab Therapeutics Inc.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by HighsLab Therapeutics Inc. · Phase 1, Interventional, and Treatment
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.
In Part 1 (Single Ascending Dose, SAD), healthy participants are randomized to receive a single fasting oral dose of HL40626S tablets or matching placebo across five sequential ascending dose cohorts. Each cohort enrolls 8 participants. Sentinel dosing is implemented for every cohort to monitor initial safety before full cohort enrolment.
In Part 2 (Multiple Ascending Dose, MAD), healthy participants are randomized to receive once-daily fasting oral doses of HL40626S tablets or matching placebo for 14 consecutive days across three sequential ascending dose cohorts. Each cohort enrolls 8 participants. All decisions to escalate to the next dose cohort were reviewed and approved by an independent Safety Review Committee (SRC) following complete data review of the preceding cohort.
Exclusion Criteria:
Any of the following ECG findings at Screening, Admission and/or pre dose on Day 1:
Healthy participants receive single fasting oral HL40626S tablets in five sequential dose-escalation cohorts. Sentinel safety evaluation is required before full cohort dosing.
Drug: HL40626S tablets
Healthy participants receive single fasting oral placebo tablets matching HL40626S, one dose per participant.
Drug: HL40626S placebo
Healthy participants receive once-daily fasting oral HL40626S tablets for 14 consecutive days across three sequential cohorts.
Drug: HL40626S tablets
Healthy participants receive once-daily oral matching placebo tablets for 14 days.
Drug: HL40626S placebo
Oral study tablets administered in a dose-escalation design
Inactive oral placebo tablets matching the active drug dose-escalation scheme
Parts 1 (SAD) and 2 (MAD): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Assess incidence, severity, causality and clinical outcome of treatment-emergent adverse events (TEAEs) graded per CTCAE Version 6.0 to characterize the safety and tolerability of HL40626S in Part 1 (SAD) and Part 2 (MAD).
Time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
Parts 1 (SAD) and 2 (MAD): Incidence of serious adverse events (SAEs) [Safety and Tolerability]
Assess Incidence, severity, causality, and clinical outcome of serious adverse events (SAEs) graded per CTCAE Version 6.0 to characterize the safety and tolerability of HL40626S in Part 1 (SAD) and Part 2 (MAD).
Time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
Parts 1 (SAD) and 2 (MAD): Proportion of participants with clinically significant abnormal findings in physical examinations, vital signs, clinical laboratory tests, and 12-lead ECG assessments relative to baseline [Safety and Tolerability]
Abnormal findings from physical examinations, vital sign measurements, laboratory analyses and 12-lead ECG tracings are compared against each participant's baseline values to support the overall safety and tolerability assessment of HL40626S in Part 1 (SAD) and Part 2 (MAD).
Time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
Part 1 (SAD): Maximum observed plasma concentration (Cmax)
Calculate peak plasma HL40626S concentration following a single fasting oral administration
Time frame: Predose up to 5 days post single dose.
Part 1 (SAD): Time to maximum observed plasma concentration (Tmax)
Record the time point corresponding to the observed Cmax after single fasting oral administration.
Time frame: Predose up to 5 days post single dose.
Part 1 (SAD): Area under the plasma concentration-time curve from time zero to last measurable concentration (AUClast)
Calculate AUClast via plasma concentration data collected over the sampling period following single-dose administration.
Time frame: Predose up to 5 days post single dose.
Part 1 (SAD): Area under the plasma concentration-time curve extrapolated to infinite time (AUCinf)
Assess the area under the plasma concentration-time curve extrapolated to infinite time (AUCinf) following single dose of HL40626S.
Time frame: Predose up to 5 days post single dose.
Part 1 (SAD): Terminal elimination rate constant (Kel)
Calculate terminal elimination rate constant following single dose of HL40626S tablets.
Time frame: Predose up to 5 days post single dose.
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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