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

NCT06640920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Uniquity One (UNI)

    lead INDUSTRY

Principal Investigators

  • Andrew W Lee, MD · Vice President, Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-10-29
Completion
2024-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640920 on ClinicalTrials.gov