Actively Recruiting
First-in-Human Single and Multiple Dose of HL-400
Led by Highlightll Pharmaceutical (USA) LLC · Updated on 2026-04-17
86
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 (a NLRP3 inhibitor) following oral single and multiple ascending dose administration.
CONDITIONS
Official Title
First-in-Human Single and Multiple Dose of HL-400
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent and follow study procedures
- Age between 18 and 65 years at screening
- Female participants must have a negative pregnancy test and agree to use contraception as specified
- Male participants with partners of reproductive potential must agree to use contraception and avoid sperm donation as specified
- Considered healthy by the investigator based on medical history, physical exam, lab tests, ECG, and vital signs
- Non-smoker for at least 6 months prior to screening
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, except for some subjects with BMI between 32.0 and 42.0 kg/m2 in specific study cohort
You will not qualify if you...
- History of significant gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, lung, neurologic, immune, or lipid metabolism disorders, or drug allergies
- Pregnant or breastfeeding women
- History of chronic diarrhea, malabsorption, unexplained weight loss, or food allergies/intolerance
- Positive blood test for HIV, hepatitis B, or hepatitis C
- Positive screen for alcohol or drugs of abuse at screening or Day -1
- Unwilling or unable to follow food and drink restrictions during the study
- Participation in any investigational drug or device study within 3 months prior to dosing
- Any condition that the investigator believes would risk participant safety or study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pharmaron CPC, Inc.
Baltimore, Maryland, United States, 21201
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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