Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing HL40626S tablets for Skin Disease

This is a single-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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.

Official registry: https://clinicaltrials.gov/study/NCT07736586 · HighsLab Therapeutics Inc. · enrollment listed as 64

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HL40626S tablets, or HL40626S placebo. The registry lists allocation as randomized. This is a single-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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.

They plan to enroll about 64 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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.

Interventions: HL40626S tablets, HL40626S placebo

Primary outcome (registry wording): Parts 1 (SAD) and 2 (MAD): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Who it is for (from inclusion criteria)

  • Ages 18 Years to 55 Years
  • Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening
  • body-mass index (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

Public study contact (from the registry)

Arockiaa P Aarthy Joseph, MBBS

61-459 361 568

a.joseph@nucleusnetwork.com.au

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT07736586 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07736586?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07736586?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary