First-in-Human Single and Multiple Dose of HL-400

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Highlightll Pharmaceutical (USA) LLC
Study ID
NCT06997484
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HL-400 — DRUG
    Part 1:Experimental: Single oral dose of HL-400, Single ascending doses, sequential assignment group design; Part 2: Experimental: Multiple oral doses of HL-400, Multiple ascending doses, QD for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.
  • Placebo — DRUG
    Part 1: Placebo comparator: Single oral dose of placebo, single doses, matching placebo; Part 2: Placebo comparator: Multiple oral doses of placebo, multiple ascending doses, QD for 14 days, matching placebo.

Study Details

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.

Key Dates

Start date
Apr 25, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Oct 27, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: HL-400
    Part 1:Experimental: Single oral dose of HL-400, Single ascending doses, sequential assignment group design; Part 2: Experimental: Multiple oral doses of HL-400, Multiple ascending doses, once a day (QD) for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.
  • Placebo Comparator: Placebo
    Part 1: Placebo comparator: Single oral dose of placebo, single doses, matching placebo; Part 2: Placebo comparator: Multiple oral doses of placebo, multiple ascending doses, QD for 14 days, matching placebo

Primary Outcome Measure

Number and percentage of participants with adverse events (AEs) [ Time Frame: From the time of taking first dose of study drug to 7 days after the last dose. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pharmaron CPC, Inc.BaltimoreMaryland21201
Kristin M. Satterfield, MD,PhD
[email protected]
240-673-0500

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