A Single-Center, Phase I, Randomized, Double- Blind, Placebo-Controlled, First-In-Man Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects

A Single-Center, Phase I, Randomized, Double- Blind, Placebo-Controlled, First-In-Man Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects - MSB0010841 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38778

Enrollment

Registered

2013-01-17

Start date

2013-02-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

illness that occurs when the body tissues are attacked by its own immune system

Interventions

Single doses of MSB0010841 will be administered by subcutaneous injection(s) at the following planned dosages: Cohort 1: 3 mg

Cohort 2: 12 mg

Cohort 3: 60 mg

Cohort 4: 120 mg

Cohort 5: 240 mg

Cohort 6: 360 mg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects, 18 - 45 yrs, inclusive, 20.0 - 30.0 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
Pharmacodynamics : Pharmacodynamics parameters Pharmacokinetics : Pharmacokinetic parameters Safety : TEAEs, local tolerability assessment, clinical laboratory and vital signs	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)