A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autoimmune Diseases
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: In total there are planned to be 2 parts to the study. Part A will look at the effects of a single dose of the study drug and Part B will look at the effects of multiple doses of the study drug.Masking: Double (Participant, Investigator)Masking Description: In each dose panel in this study, eight healthy subjects will be randomized in a 6:2 ratio to receive XNW3009 or placebo in SAD and MAD.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This study will compare SN1011 with placebo. A placebo has no active drug in it. One group of participants will take SN1011 and another group will take the placebo. The effects seen in participants taking the study drug will be compared to the effects seen in participants who are taking the placebo....
This study will compare SN1011 with placebo. A placebo has no active drug in it. One group of participants will take SN1011 and another group will take the placebo. The effects seen in participants taking the study drug will be compared to the effects seen in participants who are taking the placebo. This study will look at how participants react to and how the human body uses SN1011 at different dose levels. The design of the study is double-blind, randomised and placebo-controlled. In total there are planned to be 2 parts to the study. Part A will look at the effects of a single dose of the study drug and Part B will look at the effects of multiple doses of the study drug.
Tracking Information
- NCT #
- NCT04041544
- Collaborators
- Not Provided
- Investigators
- Not Provided