Health TrialsbyHealthPanel

A Study of HL40626S Tablets in Healthy Adults

ConditionsPsoriasis (PsO)Skin DiseaseImmune System DiseaseSkin Diseases, Papulosquamous
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • HL40626S tablets

    Drug

    Oral study tablets administered in a dose-escalation design

  • HL40626S placebo

    Drug

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

Treatment groups

64 Participants
are divided into 4 treatment groups
Group A: Part 1(SAD): HL40626SExperimental treatment 1 intervention
Group B: Part 1(SAD): PlaceboPlacebo comparator 1 intervention
Group C: Part 2 (MAD): HL40626SExperimental treatment 1 intervention
Group D: Part 2 (MAD) : PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HighsLab Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: