A randomized, adaptive, investigator/subject blind, single ascending dose, placebo-controlled phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered RO7049665 in healthy volunteers.

A randomized, adaptive, investigator/subject blind, single ascending dose, placebo-controlled phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered RO7049665 in healthy volunteers. - RO7049665 FIM SAD study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47456

Enrollment

100

Registered

2018-06-20

Start date

2017-06-14

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

Auto immune diseases

Interventions

Group - Treatment 1 RO7049665 1.5 µg* or placebo 2 RO7049665 5 µg or placebo 3 RO7049665 16 µg or placebo 4 RO7049665 55 µg or placebo 5 RO7049665 190 µg or placebo 6 RO7049665 650 µg or placebo 7 RO7

Diabetic type 1

multiple sclerosis (MS)

Psoriasis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 45 years, inclusive BMI 18.0 - 30.0 kg/m2 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
To evaluate the safety and tolerability of single-ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers.	—

Secondary

Measure	Time frame
To investigate the single dose pharmacokinetics of RO7049665 in healthy volunteers.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)