A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to investigate the safety, tolerablility, pharmacokinetics (including food and gender effect), and pharmacodynamics of LNP1955 in healthy subjects.

A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to investigate the safety, tolerablility, pharmacokinetics (including food and gender effect), and pharmacodynamics of LNP1955 in healthy subjects. - LNP1955 Single and multiple ascending dose study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42416

Enrollment

Registered

2015-05-06

Start date

2015-05-20

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Inflammatory disease conditions rheumatoid arthritis.

Interventions

Single ascending dose, multiple ascending dose, gender and food effect.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers 18-65 yrs, inclusive 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
To assess the safety and tolerability of single and multiple ascending oral doses of LNP1955 in healthy subjects.	—

Secondary

Measure	Time frame
To assess the pharmacokinetics (PK) of single and multiple ascending oral doses of LNP1955 in healthy subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)