A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants
Phase 1
Active, not recruiting
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06640920
- Lead Sponsor
- Uniquity One (UNI)
- Brief Summary
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- At the time of initial screening, in general good health (age 18 to 65 years);
Key
Exclusion Criteria
- Pregnancy or breastfeeding during the study.
- Chronic infection - Treatment with prohibited medications.
- Treatment with prohibited medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Cohort A NSI-8226 Cohort B Cohort B NSI-8226 Cohort C Cohort C NSI-8226 Cohort D Cohort D NSI-8226
- Primary Outcome Measures
Name Time Method Safety and tolerability 140 days To evaluate the incidence of treatment emergent adverse events of NSI-8826 in healthy participants according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
- Secondary Outcome Measures
Name Time Method Parameters in healthy participants 140 days Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants.
Concentration of immunogenicity 140 days Immunogenicity profile of NSI-8226 in healthy participants.
Absolute bioavailability 140 days Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants.
Trial Locations
- Locations (1)
Research Site
🇺🇸Cincinnati, Ohio, United States