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

NCT06997484 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-17

No results posted yet for this study

Summary

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

  • Parkinson Disease

Interventions

DRUG

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, QD for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.

DRUG

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.

Sponsors & Collaborators

  • Highlightll Pharmaceutical (USA) LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2026-06-30
Completion
2026-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997484 on ClinicalTrials.gov