A randomized, double-blind, placebo-controlled, alternating panel single ascending dose, sequential multiple ascending dose, and food effect study of FM101 in healthy male and female volunteers

A randomized, double-blind, placebo-controlled, alternating panel single ascending dose, sequential multiple ascending dose, and food effect study of FM101 in healthy male and female volunteers - FM101 SAD/MAD/FE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48530

Enrollment

Registered

2018-12-05

Start date

2019-01-08

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD NASH

Interventions

Part A: FM101 or placebo will be given as a drink. The volume of this drink will depend on the doses but will not be more than 240 mL. Depending on the dose you will receive, the study compound will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female subjects 18 - 50 years, inclusive, at screening BMI: 18.0-32.0 kg/m2 (inclusive)

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Adverse events (TEAEs), clinical laboratory values, vital signs, electrocardiograms (ECGs), physical examinations Plasma concentrations of FM101, derived PK parameters as applicable	—

Secondary

Measure	Time frame
Plasma concentrations of FM101, derived PK parameters as applicable	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)