NCT05740280

iCP-NI - Safety, Tolerability, Pharmacokinetic, and Immunogenicity Study in Healthy Male and Female Subjects

Terminated Phase 1 Last updated 19 September 2025

What this trial tests

Phase 1 trial testing iCP-NI in Healthy Volunteers in 24 participants. Terminated before completion.

Timeline

19 January 2023

Primary endpoint
20 April 2023

20 April 2023

Quick facts

Lead sponsor	Cellivery Therapeutics, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	19 January 2023
Primary completion	20 April 2023
Estimated completion	20 April 2023
Sites	1 location across United States

Drugs / interventions tested

• iCP-NI — full drug profile →
• Placebo

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Cellivery Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, double-blind, randomized, placebo-controlled study to investigate single and multiple intravenous infusions of improved cell-permeable nuclear import inhibitor (iCP NI) in healthy subjects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intracellular delivery of nuclear localization sequence peptide mitigates COVID-19 by inhibiting nuclear transport of inflammation-associated transcription factors.
   Lee S, Yoon SS, Jo M, Kang M, et al · · 2024 · cited 4× · PMID 37925604 · DOI 10.1016/j.ymthe.2023.11.002
2. Advances and transgressions of nuclear transport checkpoint inhibitors.
   Hawiger J. · · 2024 · cited 1× · PMID 38574737 · DOI 10.1016/j.ymthe.2024.03.021