A phase 1, randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study to evaluate the safety, tolerability and pharmacokinetics of EYP001a in healthy male subjects.

A phase 1, randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study to evaluate the safety, tolerability and pharmacokinetics of EYP001a in healthy male subjects. - EYP001a SAD and MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42859

Enrollment

Registered

2016-08-24

Start date

2016-08-30

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Hepatitis B Hepatitis B viral infection of the liver.

Interventions

Part 1: Group 1: EYP001a 30 mg or placebo Once Group 2: EYP001a 60 mg or placebo Once Group 3: EYP001a 120 mg or placebo Once Group 4: EYP001a 250 mg or placebo Once Group 5: EYP001a 500 mg or placeb

EYP001a

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers 18 - 50 years, inclusive weight more than 60 kilogram BMI 18.0 - 30.0 kilogram/meter2 non smokers

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
Primary (SAD): To determine the safety and tolerability of single doses of EYP001a as compared to placebo in healthy male subjects. To evaluate the pharmacokinetics of single doses of EYP001a in healthy male subjects. Primary (MAD): To evaluate the safety and tolerability of 14 daily doses over a period of 15 days of EYP001a as compared to placebo in healthy male subjects. To evaluate the pharmacokinetics of 14 daily doses over a period of 15 days of EYP001a in healthy male subjects.	—

Measure

Time frame

Primary (SAD): To determine the safety and tolerability of single doses of EYP001a as compared to placebo in healthy male subjects. To evaluate the pharmacokinetics of single doses of EYP001a in healthy male subjects. Primary (MAD): To evaluate the safety and tolerability of 14 daily doses over a period of 15 days of EYP001a as compared to placebo in healthy male subjects. To evaluate the pharmacokinetics of 14 daily doses over a period of 15 days of EYP001a in healthy male subjects.

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Secondary

Measure	Time frame
Secondary (SAD & MAD): To evaluate the effect of EYP001a single and multiple doses on: ALT/AST, AP, GGT, bilirubin; apolipoprotein B (apoB), apolipoprotein A1 (apoA1), cholesterol, triglycerides, HDL, LDL, prothrombin time; plasma primary and secondary bile acids, C4 (7*-hydroxy-4- cholesten-3-one), fibroblast growth factor 19 (FGF19); homeostatic model assessment of insulin resistance (HomaIR) in MAD only.	—

Measure

Time frame

Secondary (SAD & MAD): To evaluate the effect of EYP001a single and multiple doses on: ALT/AST, AP, GGT, bilirubin; apolipoprotein B (apoB), apolipoprotein A1 (apoA1), cholesterol, triglycerides, HDL, LDL, prothrombin time; plasma primary and secondary bile acids, C4 (7*-hydroxy-4- cholesten-3-one), fibroblast growth factor 19 (FGF19); homeostatic model assessment of insulin resistance (HomaIR) in MAD only.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)