NCT06640920

CompletedPhase 1

A Study to Investigate Efficacy and Safety of NSI-8226 in He...

Uniquity One (UNI)Source

Uniquity One (UNI)

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

NSI-8226-101

Study Type

interventional

Actual enrollment (reported)

48

Locations

1 country

Sites

1

Timeline

Study Start

April 29, 2024

Actual (reported)

Primary Completion

October 29, 2024

Actual (reported)

Study Completion

October 29, 2024

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 48 participants
Study completion date: October 29, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 29, 2024
Actual (reported)
First Submitted
September 13, 2024
Actual (reported)
First Posted
October 15, 2024
Actual (reported)
Primary Completion
October 29, 2024
Actual (reported)
Study Completion
October 29, 2024
Actual (reported)

Last Updated: August 12, 2025
Status Verified: August 2025
Last Update Submitted: August 7, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Safety and tolerability
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 Outcomes (3)

Absolute bioavailability
140 days
Concentration of immunogenicity
140 days
Parameters in healthy participants
140 days

Study Arms (4)

Cohort A

EXPERIMENTAL

NSI-8226

Biological: Cohort A

Cohort B

EXPERIMENTAL

NSI-8226

Biological: Cohort B

Cohort C

EXPERIMENTAL

NSI-8226

Biological: Cohort C

Interventions

Cohort ABiological

Administered IV High dose

Cohort A

Cohort BBiological

Administered SC Low Dose

Cohort B

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Uniquity One (UNI)
Industrylead

Study Sites (1)

Research Site

Cincinnati, Ohio, 45227, United States

Study Officials

Andrew W Lee, MD
Vice President, Clinical Research
STUDY CHAIR

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

October 15, 2024

Study Start

April 29, 2024

Actual (reported)

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Cohort D

EXPERIMENTAL

NSI-8226

Biological: Cohort D

Cohort CBiological

Administered SC Mid Dose

Cohort C

Cohort DBiological

Administered SC High Dose

Cohort D

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Pregnancy or breastfeeding during the study.

Chronic infection - Treatment with prohibited medications.

Treatment with prohibited medications

Contact the study team to confirm eligibility.

Primary Completion

October 29, 2024

Actual (reported)

Study Completion

October 29, 2024

Actual (reported)

Last Updated

August 12, 2025

Record last verified: 2025-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06640920
Data provider: ClinicalTrials.gov
Source updated: 2025-08-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:26 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

Cohort A

Cohort B

Cohort C

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort D

Source record

Locations