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

August 7, 2025 updated by: Uniquity One (UNI)

A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
NSI-8226
Biological: Cohort A
Administered IV High dose
Experimental: Cohort B
NSI-8226
Biological: Cohort B
Administered SC Low Dose
Experimental: Cohort C
NSI-8226
Biological: Cohort C
Administered SC Mid Dose
Experimental: Cohort D
NSI-8226
Biological: Cohort D
Administered SC High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
140 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute bioavailability
Time Frame: 140 days
Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants.
140 days
Concentration of immunogenicity
Time Frame: 140 days
Immunogenicity profile of NSI-8226 in healthy participants.
140 days
Parameters in healthy participants
Time Frame: 140 days
Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants.
140 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniquity One (UNI)

Investigators

  • Study Chair: Andrew W Lee, MD, Vice President, Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Actual)

October 29, 2024

Study Completion (Actual)

October 29, 2024

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • NSI-8226-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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