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
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 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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