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

Uniquity One (UNI)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Cohort C; Biological: Cohort D; Biological: Cohort B; Biological: Cohort A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06640920

NSI-8226-101

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups

Cohort A

Experimental group

Description:

NSI-8226

Treatment:

Biological: Cohort A

Cohort B

Experimental group

Description:

NSI-8226

Treatment:

Biological: Cohort B

Cohort C

Experimental group

Description:

NSI-8226

Treatment:

Biological: Cohort C

Cohort D

Experimental group

Description:

NSI-8226

Treatment:

Biological: Cohort D