Single and Multiple Ascending Dosing Administration of MF-300 in Healthy Participants

Part of paid clinical trials in Marlton, New Jersey.

Sponsor
Epirium Bio Inc.
Study ID
NCT07613684
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • MF-300 SAD — DRUG
    oral capsule at doses of 75mg, 125 mg, 250 mg, 500 mg, or 800 mg
  • Placebo — DRUG
    matching placebo oral capsule
  • MF-300 Food Effect — DRUG
    oral capsule at a dose of 500 mg
  • MF-300 MAD — DRUG
    oral capsule at doses of 75mg, 125 mg, or 200 mg

Study Details

The study will consist of 2 parts, Study Parts 1 (1a: single ascending dose \[SAD\] Phase; and 1b: Food Effect Phase) and Part 2 (multiple ascending dose \[MAD\] Phase). The SAD and MAD phases will evaluate separately non-elderly (≥ 18 to ≤ 65 years of age) and elderly (\> 65 to ≤75 years of age) healthy adult subjects.

Key Dates

Start date
Dec 20, 2024
Status verified
May 2026
Primary completion
Oct 9, 2025
Completion
Oct 9, 2025

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a Single Ascending Dose (SAD) MF-300
    6 out of 8 participants per cohort (up to 6 cohorts) will be randomized to receive a single dose of MF-300 in a fasted state
  • Placebo Comparator: Part 1a Single Ascending Dose (SAD) Placebo
    2 out of 8 participants per cohort (up to 6 cohorts) will be randomized to receive a single oral dose of Placebo in a fasted state
  • Experimental: Part 1b Food Effect (Fasted/Fed) MF-300
    12 participants will receive a single dose of MF-300 in fed and fasting conditions
  • Experimental: Part 2 Multiple Ascending Dose (MAD) MF-300
    8 out of 10 participants per cohort (up to 4 cohorts) will be randomized to receive once daily oral doses of MF-300 on Days 1-5 in a fasted state
  • Placebo Comparator: Part 2 Multiple Ascending Dose (MAD) Placebo
    2 out of 10 participants per cohort (up to 4 cohorts) will be randomized to receive once daily oral doses of Placebo on Days 1-5 in a fasted state

Primary Outcome Measure

Proportion of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: From admission on Day -1 to the Follow-up End of Study Visit (Day 7 for Part 1a, Day 13 for Part 1b, and Day 11 for Part 2) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Site 102MarltonNew Jersey08053-
Site 101AustinTexas78744-

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Site 102· Marlton, NJSite 101· Austin, TX

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