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

NCT05740280 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CV_iCP-NI_002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; Pneumonia; Virus Diseases; Infections

Outcome Measures

Primary Outcomes (10)

• Part A: Incidence and severity of adverse events (AEs)

  Screening to Follow Up (Day 28+2 days)

• Part B: Incidence and severity of adverse events (AEs)

  Screening to Follow Up (Day 28+2 days)

• Part A: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

  Screening to Follow Up (Day 7)

• Part B: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

  Screening to Follow Up (Day 28+2 days)

• Part A: Number of participants with abnormal 12-lead ECG parameters

  Screening to Follow Up (Day 7)

• Part B: Number of participants with abnormal 12-lead ECG parameters

  Screening to Follow Up (Day 28+2 days)

• Part A: Number of participants with abnormal vital signs measurements

  Screening to Follow Up (Day 7)

• Part B: Number of participants with abnormal vital signs measurements

  Screening to Follow Up (Day 28+2 days)

• Part A: Number of participants with abnormal physical examinations

  Screening to Follow Up (Day 7)

• Part B: Number of participants with abnormal physical examinations

  Screening to Follow Up (Day 28+2 days)

Secondary Outcomes (18)

• Part A: Pharmacokinetics (PK): Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-∞) of iCP-NI

  Day 1: Pre-dose up to 12 hours post start of infusion

• Part B: Pharmacokinetics (PK): Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-∞) of iCP-NI

  Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)

• Part A: Pharmacokinetics (PK): Area under the concentration time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of iCP-NI

  Day 1: Pre-dose up to 12 hours post start of infusion

• Part B: Pharmacokinetics (PK): Area under the concentration time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of iCP-NI

  Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)

• Part A: Pharmacokinetics (PK): Area under the concentration-time curve over a dosing interval (τ) (AUC0-τ) of iCP-NI

  Day 1: Pre-dose up to 12 hours post start of infusion

Study Arms (2)

iCP-NI

EXPERIMENTAL

Part A will comprise a single dose, sequential group design. Part A: 40 subjects will be studied in 5 groups (Groups A1 to A5). In each of Groups A1 to A5, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part A: Five proposed dose levels per protocol. Part B will comprise a multiple dose, sequential group design. Part B: 24 subjects will be studied in 3 groups (Groups B1 to B3). In each of Groups B1 to B3, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part B: Proposed dose levels to be determined following review of available data from Part A.

Drug: iCP-NI

Placebo

PLACEBO COMPARATOR

Part A will comprise a single dose, sequential group design. Part A: 40 subjects will be studied in 5 groups (Groups A1 to A5). In each of Groups A1 to A5, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part A: Five proposed dose levels per protocol. Part B will comprise a multiple dose, sequential group design. Part B: 24 subjects will be studied in 3 groups (Groups B1 to B3). In each of Groups B1 to B3, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part B: Proposed dose levels to be determined following review of available data from Part A.

Drug: Placebo

Interventions

iCP-NI DRUG

20 mg/mL iCP-NI solution for intravenous injection

iCP-NI

Placebo DRUG

Placebo solution for intravenous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must satisfy all of the following criteria at the screening visit unless otherwise stated:
• Males or females, of any race, between 18 and 55 years of age, inclusive.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive.
• In good health, determined by no clinically significant findings from medical history and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is acceptable) at screening and check in, from the physical examination performed between screening and check-in, and from the 12-lead ECG and vital signs measurements performed at screening, as assessed by the investigator (or designee).
• Females of nonchildbearing potential, defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or Mullerian agenesis) or postmenopausal. Females will not be pregnant or lactating. Males will agree to use contraception.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

You may not qualify if:

• Medical conditions
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• Any of the following:
• QTcF \>450 ms in males or \>470 ms in females, confirmed by calculating the mean of the original value and 2 repeats.
• QRS duration \>110 ms, confirmed by calculating the mean of the original value and 2 repeats
• PR interval \>220 ms, confirmed by calculating the mean of the original value and 2 repeats.
• findings that would make QTc measurements difficult or QTc data uninterpretable.
• history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
• Confirmed (eg, 2 consecutive measurements) systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, and pulse rate \>100 or \<40 beats per minute.
• Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included at the discretion of the investigator.
• Absolute neutrophil count, absolute lymphocyte count, or white blood cell count that is below the institution's lower limit of normal.
• Prior/concomitant therapy
• Administration of a COVID 19 vaccine in the 30 days prior to dosing.
• Use or intend to use any prescription medications/products within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee).

Sponsors & Collaborators

• Cellivery Therapeutics, Inc.: lead
• Labcorp Corporation of America Holdings, Inc: collaborator

Study Sites (1)

Labcorp Clinical Research Unit Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Virus Diseases; Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 23, 2023
• Study Start: January 19, 2023
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)