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

NCT07613684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MF-300 SAD

oral capsule at doses of 75mg, 125 mg, 250 mg, 500 mg, or 800 mg

DRUG

Placebo

matching placebo oral capsule

DRUG

MF-300 Food Effect

oral capsule at a dose of 500 mg

DRUG

MF-300 MAD

oral capsule at doses of 75mg, 125 mg, or 200 mg

Sponsors & Collaborators

  • Epirium Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2025-10-09
Completion
2025-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07613684 on ClinicalTrials.gov