Skin DiseasePhase 1NCT07736586
A Study of HL40626S Tablets in Healthy Adults
A Phase 1 study testing HL40626S tablets in people with Skin Disease and Immune System Disease, run by HighsLab Therapeutics Inc. at 2 sites in Australia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Disease, Immune System Disease, Skin Diseases, Papulosquamous
- What is being tested?
- HL40626S tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesAustralia
- Study dates
- 5 Aug 2026to May 2027
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Female participants must be non-pregnant and non-lactating.
- 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).
- 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).
Who cannot join
- 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 of the following ECG findings at Screening, Admission and/or pre dose on Day 1:
- 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.
- Resting HR < 40 bpm or >100 bpm when vital signs are measured at Screening
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- SARS-CoV-2 positive by PCR at Admission regardless of symptoms.
- Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia.
- 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.
- 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.
- History of cancer (malignancy) with the exception of basal or squamous cell carcinoma of the skin.
- Respiratory tract infection (upper and/or lower) treated with antibiotics within 12 weeks of Screening.
- 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.
- History of drug or alcohol abuse (as defined by DSM-V) within 12 months prior to Screening.
- Positive test result for alcohol (breath) or drugs of abuse (urine) at Screening or Admission.
- Positive serology result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.
- Active or recent herpes simplex or herpes zoster infection, if considered clinically relevant as per investigator discretion.
- Venous access considered inadequate for PK sample collection; history of evidence of adverse symptoms associated with phlebotomy or blood donation.
- 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.
- 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).
- No more than 10 standard drinks per week per NHMRC alcohol guidelines within 90 days prior to screening.
- Use of alcohol within 72 hours prior to study drug administration on Day 1.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
Hilario, +61-413 167 020, ausethicsandregulatory@nucleusnetwork.com.au
- Not yet recruiting
Nucleus Network Pty Ltd
Melbourne, 3004
Jose Garcia Hilario, +61-413 167 020, ausethicsandregulatory@nucleusnetwork.com.au
Arockiaa P Aarthy Joseph, MBBS
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, 2-Part, Phase Ι Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HL40626S Tablets Following Oral Administration of Single and Multiple Ascending Doses to Healthy Adult Participants.
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.
- Being tested
- HL40626S tablets, HL40626S placebo
- Keywords
- Phase 1, Healthy Participants, HL40626S, Oral Tablets, SAD, MAD, Safety, Pharmacokinetics, Immunogenicity, Pharmacodynamics, IL-23R
- Medical subject headings
- Skin Diseases, Immune System Diseases, Skin Diseases, Papulosquamous, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL40626S tabletsDrug
Oral study tablets administered in a dose-escalation design
HL40626S placeboDrug
Inactive oral placebo tablets matching the active drug dose-escalation scheme
| Study group | Role | What they receive |
|---|---|---|
| Part 1(SAD): HL40626S | Experimental | Healthy participants receive single fasting oral HL40626S tablets in five sequential dose-escalation cohorts. Sentinel safety evaluation is required before full cohort dosing. Receives: Drug: HL40626S tablets |
| Part 1(SAD): Placebo | Placebo comparator | Healthy participants receive single fasting oral placebo tablets matching HL40626S, one dose per participant. Receives: Drug: HL40626S placebo |
| Part 2 (MAD): HL40626S | Experimental | Healthy participants receive once-daily fasting oral HL40626S tablets for 14 consecutive days across three sequential cohorts. Receives: Drug: HL40626S tablets |
| Part 2 (MAD) : Placebo | Placebo comparator | Healthy participants receive once-daily oral matching placebo tablets for 14 days. Receives: Drug: HL40626S placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
Secondary outcomes (5)
Part 1 (SAD): Maximum observed plasma concentration (Cmax)
Calculate peak plasma HL40626S concentration following a single fasting oral administration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Predose up to 5 days post single dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start5 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseaseStudies 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
- Sequential
- Model description
- Sequential dose-escalation design with separate single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, randomized double-blind placebo control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighsLab Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736586
- Sponsor's protocol ID
- HLD25011-P1-1
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, 2-Part, Phase Ι Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HL40626S Tablets Following Oral Administration of Single and Multiple Ascending Doses to Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT07736586
- Acronym / sponsor ID
- HLD25011-P1-1
- Keywords
- Phase 1, Healthy Participants, HL40626S, Oral Tablets, SAD, MAD, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- HighsLab Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Jul 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Sequential dose-escalation design with separate single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, randomized double-blind placebo control.
| Arm | Type | Receives |
|---|---|---|
| Part 1(SAD): HL40626S | Experimental | Drug: HL40626S tabletsHealthy participants receive single fasting oral HL40626S tablets in five sequential dose-escalation cohorts. Sentinel safety evaluation is required before full cohort dosing. |
| Part 1(SAD): Placebo | Placebo comparator | Drug: HL40626S placeboHealthy participants receive single fasting oral placebo tablets matching HL40626S, one dose per participant. |
| Part 2 (MAD): HL40626S | Experimental | Drug: HL40626S tabletsHealthy participants receive once-daily fasting oral HL40626S tablets for 14 consecutive days across three sequential cohorts. |
| Part 2 (MAD) : Placebo | Placebo comparator | Drug: HL40626S placeboHealthy participants receive once-daily oral matching placebo tablets for 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- Female participants must be non-pregnant and non-lactating.
Key exclusion criteria (23 listed)
- 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 of the following ECG findings at Screening, Admission and/or pre dose on Day 1:
- Resting HR < 40 bpm or >100 bpm when vital signs are measured at Screening
- SARS-CoV-2 positive by PCR at Admission regardless of symptoms.
- Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia.
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 |
|---|---|---|
| HL40626S tabletsOral study tablets administered in a dose-escalation design | Drug | Part 1(SAD): HL40626S, Part 2 (MAD): HL40626S |
| HL40626S placeboInactive oral placebo tablets matching the active drug dose-escalation scheme | Drug | Part 1(SAD): Placebo, Part 2 (MAD) : Placebo |
Primary outcome
Parts 1 (SAD) and 2 (MAD): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
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).
Parts 1 (SAD) and 2 (MAD): Incidence of serious adverse events (SAEs) [Safety and Tolerability]
Time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
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).
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]
Time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.
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).
5 secondary outcomes
Part 1 (SAD): Maximum observed plasma concentration (Cmax)
Time frame: Predose up to 5 days post single dose.
Part 1 (SAD): Time to maximum observed plasma concentration (Tmax)
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)
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)
Time frame: Predose up to 5 days post single dose.
Part 1 (SAD): Terminal elimination rate constant (Kel)
Time frame: Predose up to 5 days post single dose.
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HL40626S tablets in people with Skin Disease and Immune System Disease, run by HighsLab Therapeutics Inc. at 2 sites 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 7 inclusion and 23 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Arockiaa P Aarthy Joseph, MBBS (61-459 361 568, a.joseph@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 (SAD) and 2 (MAD): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From signed informed consent through Day 15 for SAD and Day 29 for MAD.). The study lists 3 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 29 Oct 2026.