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

NCT ID: NCT06640920

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2024-10-29

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort A

NSI-8226

Group Type EXPERIMENTAL

Cohort A

Intervention Type BIOLOGICAL

Administered IV High dose

Cohort B

NSI-8226

Group Type EXPERIMENTAL

Cohort B

Intervention Type BIOLOGICAL

Administered SC Low Dose

Cohort C

NSI-8226

Group Type EXPERIMENTAL

Cohort C

Intervention Type BIOLOGICAL

Administered SC Mid Dose

Cohort D

NSI-8226

Group Type EXPERIMENTAL

Cohort D

Intervention Type BIOLOGICAL

Administered SC High Dose

Interventions

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Cohort A

Administered IV High dose

Intervention Type BIOLOGICAL

Cohort B

Administered SC Low Dose

Intervention Type BIOLOGICAL

Cohort C

Administered SC Mid Dose

Intervention Type BIOLOGICAL

Cohort D

Administered SC High Dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Pregnancy or breastfeeding during the study.
2. Chronic infection - Treatment with prohibited medications.
3. Treatment with prohibited medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uniquity One (UNI)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew W Lee, MD

Role: STUDY_CHAIR

Vice President, Clinical Research

Locations

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Research Site

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NSI-8226-101

Identifier Type: -

Identifier Source: org_study_id

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