A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants

Uniquity One (UNI)1 site in 1 country48 target enrollmentApril 29, 2024

ConditionsHealthy

InterventionsCohort A Cohort B Cohort C Cohort D

Overview

Phase: Phase 1
Intervention: Cohort A
Conditions: Healthy
Sponsor: Uniquity One (UNI)
Enrollment: 48
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.

Registry

clinicaltrials.gov

Start Date

April 29, 2024

End Date

October 29, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Uniquity One (UNI)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At the time of initial screening, in general good health (age 18 to 65 years);

Exclusion Criteria

•Pregnancy or breastfeeding during the study.
•Chronic infection - Treatment with prohibited medications.
•Treatment with prohibited medications

Arms & Interventions

Cohort A

NSI-8226

Intervention: Cohort A

Cohort B

NSI-8226

Intervention: Cohort B

Cohort C

NSI-8226

Intervention: Cohort C

Cohort D

NSI-8226

Intervention: Cohort D

Outcomes

Primary Outcomes

Safety and tolerability

Time Frame: 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