Double-blind, placebo-controlled, multiple ascending-dose study to investigate the safety and tolerability of AZ01 in healthy volunteers.

Double-blind, placebo-controlled, multiple ascending-dose study to investigate the safety and tolerability of AZ01 in healthy volunteers. - AZ01 (PEGYLATED INTERFERON BETA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36500

Enrollment

Registered

2009-11-27

Start date

2010-01-04

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

Multiple Sclerosis

Interventions

Study Medication: Active substance : AZ01 Activity : unknown Indication : unknown Strength : 1.5 mg/mL Dosage form : SC injection Treatments: Cohort G: 7.5 mg dose of AZ01 manufactured with improved

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy men and women, 18 and 45 years of age, inclusive, BMI 18 and 30 kg/m2, max. 5 cigarettes smoking per day.

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer 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) / more than 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Plasma AZ01 concentrations, pharmacokinetic parameters. Safety: Adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, TSH and antibodies to AZ01. Pharmacodynamics: Plasma markers (neopterin), quantitative gene expression (MxA and OAS).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)