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

Completed

• Conditions: Disorder in which the body makes antibodies against bodys own proteins; 10003816

• Registration Number: NL-OMON36904
• Lead Sponsor: Kineta One

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: plasma drug concentrations, pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>