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Not yet recruitingNCT07736586Updated Aug 3, 2026

A Study of HL40626S Tablets in Healthy Adults

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

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Psoriasis (PsO)
  • Skin Disease
  • Immune System Disease
  • Skin Diseases, Papulosquamous

Keywords

  • Phase 1
  • Healthy Participants
  • HL40626S
  • Oral Tablets
  • SAD
  • MAD
  • Safety
  • Pharmacokinetics
  • Immunogenicity
  • Pharmacodynamics
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening.
  3. BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening, with a body weight ≥ 50 kg.
  4. In good general health, as determined by the Investigator.
  5. Female participants must be non-pregnant and non-lactating.
  6. Female participants must be of non-childbearing potential, or agree to use dual contraception methods (female participants exclusively in same-sex relationships are exempt from the above contraception requirements), and abstain from ova (egg) donation throughout the entire duration of the study and for at least 90 days after the last dose, and have negative pregnancy test results at Screening (serum) and Day -1 (urine). (Note: As this is a first-in-human [FIH] study, the applicable t₁/₂ and corresponding restriction period may be adjusted based on emerging PK data).
  7. Male participants with female partners of reproductive potential must agree to practice complete abstinence or to use a condom (male participant) plus an additional highly effective method (female partner) of contraception for the duration of the study and for at least 90 days after last dosing (Male participants exclusively in same-sex relationships are exempt from the above contraception requirements); all male participants must also agree to refrain from sperm donation for at least 90 days after the last dose. (Note: As this is a FIH study, the applicable t₁/₂ and corresponding restriction period will be adjusted based on real-time PK data).

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Any of the following ECG findings at Screening, Admission and/or pre dose on Day 1:

    1. Any out-of-range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator.
    2. 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).
    3. Participants with QTcF >450 msec (if male) or >470 msec (if female) will be excluded.
  3. Resting HR \< 40 bpm or >100 bpm when vital signs are measured at Screening
  4. SARS-CoV-2 positive by PCR at Admission regardless of symptoms.
  5. Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia.
  6. Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as ALT, AST, gamma glutamyltransferase (GGT), alkaline phosphatase (ALP) or total/direct bilirubin > upper limit of the reference range (ULRR) at Screening or Admission. Participants with confirmed Gilbert's syndrome will not be permitted to enroll in the study.
  7. Indications of pre-metabolic syndrome and/or systemic inflammation, as suggested by high-sensitivity C-reactive protein (hsCRP) of > 3 mg/L, elevated erythrocyte sedimentation rate (Male ≥ 15 mm/hr, Female ≥ 20 mm/hr) or Hemoglobin A1c (HbA1c) >5.3% at Screening.
  8. History of cancer (malignancy) with the exception of basal or squamous cell carcinoma of the skin.
  9. Respiratory tract infection (upper and/or lower) treated with antibiotics within 12 weeks of Screening.
  10. Clinically significant infection or known inflammatory condition or history of clinically significant infection within 28 days prior to study drug administration on Day 1 that, in the opinion of the Investigator, would affect the participant's ability to participate in the trial.
  11. History of drug or alcohol abuse (as defined by DSM-V) within 12 months prior to Screening.
  12. Positive test result for alcohol (breath) or drugs of abuse (urine) at Screening or Admission.
  13. Positive serology result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.
  14. Active or recent herpes simplex or herpes zoster infection, if considered clinically relevant as per investigator discretion.
  15. Venous access considered inadequate for PK sample collection; history of evidence of adverse symptoms associated with phlebotomy or blood donation.
  16. Participation in a study of any investigational drug, device, biologic or other agent within 30 days (or 5 half-lives, whichever is longer [as applicable]) prior to Day 1.
  17. Loss or donation of blood >500 mL (within 30 days prior to Screening); donation of bone marrow or peripheral stem cells (within 90 days prior to Day 1); or donation of plasma (within 7 days prior to Screening).
  18. No more than 10 standard drinks per week per NHMRC alcohol guidelines within 90 days prior to screening.
  19. Use of alcohol within 72 hours prior to study drug administration on Day 1.
  20. Use of prescription drugs within 14 days (or 5 half-lives, whichever is longer), or non-prescription drugs and/or herbal supplements within 7 days (or 5 half-lives, whichever is longer) prior to study drug administration on Day 1. Exception: hormonal contraceptives, acetaminophen ≤ 1 gram/day or ibuprofen ≤ 800 mg/day may be administered at Investigator's discretion.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Part 1(SAD): HL40626S

    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

  • Placebo comparator
    Part 1(SAD): Placebo

    Healthy participants receive single fasting oral placebo tablets matching HL40626S, one dose per participant.

    Drug: HL40626S placebo

  • Experimental
    Part 2 (MAD): HL40626S

    Healthy participants receive once-daily fasting oral HL40626S tablets for 14 consecutive days across three sequential cohorts.

    Drug: HL40626S tablets

  • Placebo comparator
    Part 2 (MAD) : Placebo

    Healthy participants receive once-daily oral matching placebo tablets for 14 days.

    Drug: HL40626S placebo

Interventions

  • DrugHL40626S tablets

    Oral study tablets administered in a dose-escalation design

  • DrugHL40626S placebo

    Inactive oral placebo tablets matching the active drug dose-escalation scheme

05

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07736586
Lead sponsor
HighsLab Therapeutics Inc.
Responsible party
Sponsor
First posted
Jul 30, 2026
Start date
Aug 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

Arockiaa P Aarthy Joseph, MBBS
Contact
a.joseph@nucleusnetwork.com.au
61-459 361 568

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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