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Completed

NCT Number: NCT06640920

A Study to Investigate Efficacy and Safety 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Treatment and study plan

Cohort A

Biological

Administered IV High dose

Cohort B

Biological

Administered SC Low Dose

Cohort C

Biological

Administered SC Mid Dose

Cohort D

Biological

Administered SC High Dose

Primary outcomes

  1. 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

Secondary outcomes

  1. Absolute bioavailability

    Time frame: 140 days

    Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants.

  2. Concentration of immunogenicity

    Time frame: 140 days

    Immunogenicity profile of NSI-8226 in healthy participants.

  3. Parameters in healthy participants

    Time frame: 140 days

    Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants.

Sponsors and collaborators

Lead sponsor

Uniquity One (UNI)

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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