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

NCT07613684 | Completed Phase 1 FDA Drug

• 1 other identifier: MF-300-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

SAD; MAD; Food Effect; Non-Elderly; Elderly

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with treatment-emergent adverse events (TEAEs)

  Treatment-emergent AEs (TEAEs): AE that either commenced following initiation of study treatment or was present prior to study treatment but increased in frequency or severity following initiation of study treatment

  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)

• Proportion of participants with serious adverse events (SAEs)

  An SAE is any untoward medical occurrence at any dose which results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (IME)

  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)

• Proportion of participants with any TEAE leading to premature discontinuation of study intervention

  Treatment-emergent AEs (TEAEs): AE that either commenced following initiation of study treatment or was present prior to study treatment but increased in frequency or severity following initiation of study treatment

  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)

Secondary Outcomes (9)

• Part 1 SAD Cmax

  up to 72 hours

• Part 1 SAD Tmax

  up to 72 hours

• Part 1 SAD t½

  up to 72 hours

• Part 1 SAD AUC0-∞

  up to 72 hours

• Part 2 MAD Cmax

  up to Day 6

Study Arms (5)

Part 1a Single Ascending Dose (SAD) MF-300

EXPERIMENTAL

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

Drug: MF-300 SAD

Part 1a Single Ascending Dose (SAD) Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 1b Food Effect (Fasted/Fed) MF-300

EXPERIMENTAL

12 participants will receive a single dose of MF-300 in fed and fasting conditions

Drug: MF-300 Food Effect

Part 2 Multiple Ascending Dose (MAD) MF-300

EXPERIMENTAL

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

Drug: MF-300 MAD

Part 2 Multiple Ascending Dose (MAD) Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MF-300 SAD DRUG

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

Also known as: MF-300

Part 1a Single Ascending Dose (SAD) MF-300

Placebo DRUG

matching placebo oral capsule

Part 1a Single Ascending Dose (SAD) Placebo; Part 2 Multiple Ascending Dose (MAD) Placebo

MF-300 Food Effect DRUG

oral capsule at a dose of 500 mg

Also known as: MF-300

Part 1b Food Effect (Fasted/Fed) MF-300

MF-300 MAD DRUG

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

Also known as: MF-300

Part 2 Multiple Ascending Dose (MAD) MF-300

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Elderly Cohorts:
• Healthy male or non-pregnant, non-lactating female subjects ≥ 18 to ≤ 65 years of age at time of first dosing.
• Body mass index (BMI) within the range ≥ 18.0 to ≤ 35.0 kg/m2.
• Subjects in the food effect cohort must be willing to eat a high fat breakfast, including butter and turkey bacon or sausage.
• Female subjects must either:
• have no childbearing potential by reason of surgery (e.g., hysterectomy, bilateral oophorectomy, salpingectomy in documented medical history) or be at least 1 year post-menopausal (e.g., 12 months without menstrual period without other medical cause), and have menopause confirmed with follicle-stimulating hormone level of \>40 IU/L at screening in women not taking hormone contraceptive or hormone replacement therapy. Note: Documentation can come from the study center personnel's: review of the subject's medical records, medical examination, or medical history interview.
• if of child-bearing potential, must be truly abstinent of heterosexual intercourse as their usual and preferred lifestyle practicing abstinence and agree to remain abstinent for the duration of the study or subject's heterosexual partner is non-fertile (e.g. at least 90 days post-vasectomy from screening) or subjects are using and willing to continue using two medically acceptable forms of birth control for at least 30 days prior to screening (at least 90 days for oral and transdermal contraceptives) and at least 30 days after the last study drug administration. Acceptable forms of contraception include: bilateral tubal ligation or occlusion, oral or injectable hormonal contraceptives, contraceptive patch, hormonal and non-hormonal intra uterine devices, vaginal hormonal rings, vaginal diaphragm, or cervical caps, in addition to having their male partner use a condom plus spermicide agent.
• Male subjects must be non-fertile, vasectomized (vasectomy performed 4 months or more prior to the first dosing), or truly abstinent of heterosexual intercourse as their usual and preferred lifestyle and agree to remain abstinent for duration of study and for 90 days from last administration of study drug or heterosexual partner is not of child bearing potential or subject is willing to continue using two medically acceptable form of birth control from Day -1 until at least 90 days after the last administration of study drug. Highly effective contraceptive methods include:
• Use of a condom plus spermicide agent from the time of informed consent until 90 days after the last administration of study drug.
• Subject's sexual partner is of non-childbearing potential, i.e., post-menopausal or surgically sterilized
• If subject's partner is of childbearing potential, she is using an acceptable form of contraception such as: bilateral tubal ligation or occlusion, oral or injectable hormonal contraceptives, contraceptive patch, hormonal and non-hormonal intra uterine devices, vaginal hormonal rings, vaginal diaphragm, or cervical caps
• Male subjects must agree not to donate sperm from the first dosing until 90 days after the last dose.
• Capable of giving signed informed consent that includes agreement to comply with the requirements and restrictions listed in the ICF and in this protocol.
• Elderly Cohorts:
• Healthy male or non-pregnant, non-lactating female subjects \> 65 to ≤ 75 years of age at time of first dosing. Subjects with a history of and/or current well-controlled medical conditions may be enrolled so long as the investigator, in consultation with the medical monitor, are of the opinion that such conditions will not interfere with the safety of the subjects and that the subjects are otherwise in good general health. Some examples of allowable well-controlled medical conditions, in otherwise healthy subjects, include, but are not limited to the following:

You may not qualify if:

• Non-Elderly Cohorts:
• Subjects who meet any of the following criteria will be excluded from participating in the study:
• History of or current clinically significant medical illness including, but not limited to, any cardiovascular disease (including blood pressure or rhythm disturbance requiring constant monitoring), hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, or any other illness that the Investigator considers should exclude the subject or that could interfere with the safety of the subjects, or might confound the study results.
• Has acute or chronic GI conditions (e.g., gastroesophageal reflux disease, peptic ulcer, active and chronic colitis, cholecystectomy, small or large bowel resection, gastric bypass or equivalent) that would interfere with drug tolerance or absorption.
• Has history of migraine headaches requiring medical attention or active treatment within the past 6 months from screening.
• Has visible sunburn at admission
• Has a history of hypersensitivity/photosensitivity dermatosis within the past 5 years,
• Has another active dermatological pathology at screening or admission excluding dry skin or acne, deemed clinically significant by the Investigator.
• Has a history of or active ocular pathology or clinically significant findings in the Investigator opinion on ophthalmology exam at screening (Note: normal slit exam (glaucoma, cataract) will be sufficient to exclude sensitivity to phototoxicity).
• Clinically significant abnormalities in results of laboratory tests, such as clinically significant abnormal hematology, clinical chemistry, thyroid, or urinalysis at screening or at the time of admission, as per Investigator's judgment; Note: Repeat testing is allowed at Investigator discretion.
• Liver impairment defined as AST and/or ALT \> ULN; or kidney impairment defined as eGFR \< 90 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
• Clinically significant abnormal physical examination or vital signs as determined by the Investigator.
• Clinically significant, abnormal 12 lead ECG as determined by the Investigator, including average QTcF \> 450 ms for males and \>470 ms for females. Note: Repeat testing is allowed at Investigator discretion.
• Blood pressure less than 90/40 mmHg or greater than 140/90 mmHg. Heart rate lower than 40 bpm or higher than 99 bpm. Subjects should be seated or semi-supine for a minimum of 5 minutes. Vital signs may be repeated once (once at screening and once at admission) at the discretion of the PI or designee.
• History of or positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) antibody.

Sponsors & Collaborators

• Epirium Bio Inc.: lead

Study Sites (2)

Site 102

Marlton, New Jersey, 08053, United States

Location

Site 101

Austin, Texas, 78744, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A site pharmacist or designee was responsible for maintaining the blind throughout the SAD (Part 1a) and MAD (Part 2) portions of the study. The food effect (Part 1b) portion of the study was open-label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 29, 2026
• Study Start: December 20, 2024
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)