A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers

Future Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Single ascending doses of FM101; Drug: Multiple ascending doses of FM101; Drug: Food effects of FM101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03879928

FM101-CTP1-001

Details and patient eligibility

About

This a double blind, randomized, placebo controlled, single and multiple ascending dose (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs), clinical laboratory values, vital signs, ECGs, and physical examinations.

Full description

This is a randomized, double-blind, placebo-controlled study in healthy volunteers designed to assess the safety, tolerability and PK of FM101. This study will consist of 3 parts: a SAD part, a single dose FE part and a MAD part. Each subject is to participate in only 1 part of the study.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gender: male or female
• Age: 18 - 50 years, inclusive, at screening
• Body mass index (BMI) : 18.0 - 32.0 kg/m2 (inclusive)
• Weight : ≥ 50 kg
• Status : healthy subjects
• At screening, females must be non-pregnant and non-lactating, or of non child-bearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhea duration of 12 consecutive months); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, and a urine pregnancy test at each admission and at follow-up.
• Female subjects of child-bearing potential, with a fertile male sexual partner, must agree to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
• Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
• All prescribed medication must have been stopped at least 14 days prior to (each) admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
• All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 7 days prior to (each) admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center.
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), grapefruit (juice), and tobacco products from 48 hours prior to (each) admission to the clinical research center.
• Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
• Willing and able to sign the ICF.

Exclusion criteria

• Employee of CRO or the Sponsor.
• History of relevant drug and/or food allergies.
• Using tobacco products within 60 days prior to (the first) drug administration.
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
• Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid [GHB], tricyclic antidepressants, and alcohol) at screening and (each) admission to the clinical research center.
• Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
• Positive screen for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, or anti human immunodeficiency virus (HIV) 1 and 2 antibodies.
• Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 3 other drug studies (for male subjects) / more than 2 other drug studies (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
• Donation or loss of more than 100 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
• Significant and/or acute illness within 5 days prior to (the first) drug administration that may impact safety assessments, in the opinion of the Investigator.
• Non-willingness to consume the high-fat breakfast (Part B only).
• Unsuitable veins for infusion or blood sampling.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 13 patient groups, including a placebo group

Placebo for SAD

Placebo Comparator group

Description:

Placebo comparator for SAD

Treatment:

Drug: Single ascending doses of FM101

FM101 75 mg for SAD

Experimental group

Description:

Single ascending doses of FM101

Treatment:

Drug: Single ascending doses of FM101

FM101 150 mg for SAD

Experimental group

Description:

Single ascending doses of FM101

Treatment:

Drug: Single ascending doses of FM101

FM101 300 mg for SAD

Experimental group

Description:

Single ascending doses of FM101

Treatment:

Drug: Single ascending doses of FM101

FM101 600 mg for SAD

Experimental group

Description:

Single ascending doses of FM101

Treatment:

Drug: Single ascending doses of FM101

FM101 1200 mg for SAD

Experimental group

Description:

Single ascending doses of FM101

Treatment:

Drug: Single ascending doses of FM101

FM101 2400 mg for SAD

Experimental group

Description:

Single ascending doses of FM101

Treatment:

Drug: Single ascending doses of FM101

Placebo for MAD

Placebo Comparator group

Description:

Placebo comparator for MAD

Treatment:

Drug: Multiple ascending doses of FM101

FM101 150 mg (QD) for MAD

Experimental group

Description:

Multiple ascending doses of FM101

Treatment:

Drug: Multiple ascending doses of FM101

FM101 450 mg (QD) for MAD

Experimental group

Description:

Multiple ascending doses of FM101

Treatment:

Drug: Multiple ascending doses of FM101

FM101 600 mg (BID) for MAD

Experimental group

Description:

Multiple ascending doses of FM101

Treatment:

Drug: Multiple ascending doses of FM101

FM101 300 mg under fasted condition for FE

Experimental group

Description:

Food Effect of FM101

Treatment:

Drug: Food effects of FM101

FM101 300 mg under fed condition for FE

Experimental group

Description:

Food Effect of FM101

Treatment:

Drug: Food effects of FM101