NCT06640920

A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Uniquity One (UNI) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Cohort A	Administered IV High dose
BIOLOGICAL	Cohort B	Administered SC Low Dose
BIOLOGICAL	Cohort C	Administered SC Mid Dose
BIOLOGICAL	Cohort D	Administered SC High Dose

Timeline

• Start date: 2024-04-29
• Primary completion: 2024-10-29
• Completion: 2024-10-29
• First posted: 2024-10-15
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study