A PHASE 1, THREE-PART, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF AQX-1125 IN HEALTHY HUMAN SUBJECTS

A PHASE 1, THREE-PART, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF AQX-1125 IN HEALTHY HUMAN SUBJECTS - AQX-1125 Phase 1 SAD/MAD/FE study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34539

Enrollment

Registered

2010-12-21

Start date

2011-01-24

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

arthritis asthma Inflammatory disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy men and women - 18 - 45 years of age, inclusive; - BMI 19.9 - 29.9 kg/m2, inclusive; - Non smoking

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, hepatitis C or HIV/AIDS. In case of participation in another drug study within 60 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 (for men) or more than 1.0 liters of blood (for woman) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics Pharmacodynamics Safety	—

Secondary

Measure	Time frame
N.a.	—

Countries

Netherlands

Outcome results