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

NCT05740280 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

iCP-NI

20 mg/mL iCP-NI solution for intravenous injection

DRUG

Placebo

Placebo solution for intravenous injection

Sponsors & Collaborators

  • Labcorp Corporation of America Holdings, Inc

    collaborator INDUSTRY
  • Cellivery Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2023-04-20
Completion
2023-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740280 on ClinicalTrials.gov