NCT06640920

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2024

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

September 13, 2024

Last Update Submit

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

Cohort D

EXPERIMENTAL

NSI-8226

Biological: Cohort D

Interventions

Cohort ABIOLOGICAL

Administered IV High dose

Cohort A
Cohort BBIOLOGICAL

Administered SC Low Dose

Cohort B
Cohort CBIOLOGICAL

Administered SC Mid Dose

Cohort C
Cohort DBIOLOGICAL

Administered SC High Dose

Cohort D

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:

  • Pregnancy or breastfeeding during the study.
  • Chronic infection - Treatment with prohibited medications.
  • Treatment with prohibited medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Cincinnati, Ohio, 45227, United States

Location

Study Officials

  • Andrew W Lee, MD

    Vice President, Clinical Research

    STUDY CHAIR

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

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

US(1)