Healthy
Conditions
Brief summary
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.
Interventions
Sponsors
Uniquity One (UNI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1\. At the time of initial screening, in general good health (age 18 to 65 years); Key
Exclusion criteria
1. Pregnancy or breastfeeding during the study. 2. Chronic infection - Treatment with prohibited medications. 3. Treatment with prohibited medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute bioavailability | 140 days | Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants. |
| Concentration of immunogenicity | 140 days | Immunogenicity profile of NSI-8226 in healthy participants. |
| Parameters in healthy participants | 140 days | Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants. |
Countries
United States
Outcome results
None listed