A Study to Assess Safety, Tolerability and Exposure of 4ET1103 in Healthy Human Volunteers

Part of paid clinical trials in Austin, Texas.

Sponsor
4E Therapeutics
Study ID
NCT07586514
Phase
PHASE1
Status
Completed

Conditions

  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Treatment for neuropathic pain — DRUG
    MNK inhibitor for treatment of neuropathic pain
  • placebo — DRUG
    placebo for MNK inhibitor

Study Details

This study will dose healthy human volunteers with either active drug (4ET1103) or placebo. Each study subject will receive a single dose of either active drug or placebo, and will then be monitored for safety, tolerability and exposure of active drug.

Key Dates

Start date
Apr 18, 2025
Status verified
May 2026
Primary completion
Aug 18, 2025
Completion
Aug 18, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 active
    45 mg active
  • Placebo Comparator: Cohort 1 placebo
    placebo for 45 mg
  • Experimental: Cohort 2 active
    135 mg 4ET1103
  • Placebo Comparator: Cohort 2 placebo
    placebo for 135 mg
  • Experimental: Cohort 3 active
    270 mg 4ET1103
  • Placebo Comparator: Cohort 3 placebo
    placebo for 270 mg
  • Experimental: Cohort 4 active
    450 mg 4ET1103
  • Placebo Comparator: Cohort 4 placebo
    placebo for 450 mg
  • Experimental: cohort 5 active
    720 mg 4ET1103
  • Placebo Comparator: cohort 5 placebo
    placebo for 720 mg

Primary Outcome Measure

Change from baseline in hematology parameters [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
PPDAustinTexas78744-

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PPD· Austin, TX

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