A DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF A SUBCUTANEOUS DOSE OF SHK-186 IN HEALTHY SUBJECTS

A DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF A SUBCUTANEOUS DOSE OF SHK-186 IN HEALTHY SUBJECTS - ShK-186 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36904

Enrollment

Registered

2012-07-04

Start date

2012-08-27

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

Disorder in which the body makes antibodies against bodys own proteins

Interventions

Group 1: one 5 mcg SC injection of ShK-186 or placebo on Day 1, after an overnight fast Group 2: one 15 mcg SC injection of ShK-186 or placebo on Day 1, after an overnight fast Group 3: one 30 mcg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male and female subjects - 18-45 yrs, inclusive - BMI: 18.0-30.0 kg/m2, inclusive and weigh > 50 kg - the volunteers did not smoke during at least 30 days prior to the screening

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
Pharmacokinetics: plasma drug concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)