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Healthy VolunteersPhase 1NCT05740280

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

A Phase 1 study testing iCP-NI in people with Healthy Volunteers, run by Cellivery Therapeutics, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
iCP-NI
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
19 Jan 2023to 20 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 31Show fewer
  • 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).
  • Use or intend to use slow release medications/products considered to still be active within 14 days prior to check in, unless deemed acceptable by the investigator (or designee).
  • Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to check in, unless deemed acceptable by the investigator (or designee).
  • Prior/concurrent clinical study experience
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days (or 5 half-lives, whichever is longer) prior to dosing.
  • Have previously completed or withdrawn from this study or any other study investigating iCP-NI, and have previously received iCP-NI.
  • Diet and lifestyle
  • Alcohol consumption of >21 units per week for males and >14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
  • Positive urine drug screen at screening or check-in or positive alcohol urine or breath test result at check in.
  • History of alcoholism or drug/chemical abuse within 2 years prior to check in.
  • Use of tobacco or nicotine containing products within 3 months prior to check in.
  • Ingestion of poppy seed containing foods or beverages within 7 days prior to check-in.
  • Other exclusions
  • Receipt of blood products within 2 months prior to check in.
  • Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
  • Poor peripheral venous access.
  • Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Labcorp Clinical Research Unit Inc.

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: iCP-NI - A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Intravenous Infusion, Safety, Tolerability, Pharmacokinetic, and Immunogenicity Study in Healthy Male and Female Subjects

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.

Read the detailed description

Improved cell-permeable nuclear import inhibitor (iCP-NI) is a synthetically manufactured, cell-penetrating peptide which has been developed by fusion of advanced macromolecule transduction domain of hydrophobic cell-permeable peptide and nuclear factor kappa-light- chain-enhancer of activated B cells (NF-κB)-derived nuclear localization sequence.

The production and secretion of cytokines from innate immune cells are critical responses to inflammation and infection in the body.

iCP-NI is a binding competitor that inhibits the interaction of nuclear transfer material proteins such as IATF (NF-BB, STAT, AP-1, NFAT) and importin alpha5, inhibiting the nuclear transport of IATF to prevent inflammatory cytokine transcription.

This study is the first-human clinical trial for iCP-NI which is intended to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of iCP-NI.

Being tested
iCP-NI, Placebo
Keywords
COVID-19, Pneumonia, Virus Diseases, Infections
Medical subject headings
COVID-19, Pneumonia, Virus Diseases, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCP-NIDrug

    20 mg/mL iCP-NI solution for intravenous injection

  • PlaceboDrug

    Placebo solution for intravenous injection

Study groups in NCT05740280
Study groupRoleWhat they receive
iCP-NIExperimentalPart 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.
Receives: Drug: iCP-NI
PlaceboPlacebo comparatorPart 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Screening to Follow Up (Day 28+2 days)

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

    Measured: Screening to Follow Up (Day 28+2 days)

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

    Measured: Screening to Follow Up (Day 7)

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

    Measured: Screening to Follow Up (Day 28+2 days)

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

    Measured: Screening to Follow Up (Day 7)

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

    Measured: Screening to Follow Up (Day 28+2 days)

  7. Part A: Number of participants with abnormal vital signs measurements

    Measured: Screening to Follow Up (Day 7)

  8. Part B: Number of participants with abnormal vital signs measurements

    Measured: Screening to Follow Up (Day 28+2 days)

  9. Part A: Number of participants with abnormal physical examinations

    Measured: Screening to Follow Up (Day 7)

  10. Part B: Number of participants with abnormal physical examinations

    Measured: Screening to Follow Up (Day 28+2 days)

Secondary outcomes (18)

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

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

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

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

  3. 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

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

  4. 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

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

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

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

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

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

  7. Part A: Pharmacokinetics (PK): Maximum observed concentration (Cmax) of iCP-NI

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

  8. Part B: Pharmacokinetics (PK): Maximum observed concentration (Cmax) of iCP-NI

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

  9. Part A: Pharmacokinetics (PK): Time of the maximum observed concentration (tmax) of iCP-NI

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

  10. Part B: Pharmacokinetics (PK): Time of the maximum observed concentration (tmax) of iCP-NI

    Measured: Day 1 (pre-dose) up to Day 7 (12 hours post start of infusion)

  11. Part A: Pharmacokinetics (PK): Apparent terminal elimination half life (t1/2) of iCP-NI

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

  12. Part B: Pharmacokinetics (PK): Apparent terminal elimination half life (t1/2) of iCP-NI

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

  13. Part A: Pharmacokinetics (PK): Accumulation ratio based on AUC0-τ (ARAUC) of iCP-NI

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

  14. Part B: Pharmacokinetics (PK): Accumulation ratio based on AUC0-τ (ARAUC) of iCP-NI

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

  15. Part A: Serum concentrations of anti-iCP-NI antibodies

    Serum concentrations of anti-iCP-NI antibodies will be determined using a validated analytical procedure.

    Measured: Day -1, Follow up (Day 7) and Immunogenicity Visit (Day 28 + 2 days)

  16. Part B: Serum concentrations of anti-iCP-NI antibodies

    Serum concentrations of anti-iCP-NI antibodies will be determined using a validated analytical procedure.

    Measured: Day -1, Day 7 (pre-am dose) and Follow up (Day 28 + 2 days)

  17. Part A: Serum concentrations of neutralizing antibodies

    Serum concentrations of neutralizing antibodies will be determined using a validated analytical procedure.

    Measured: Day -1, Follow up (Day 7) and Immunogenicity Visit (Day 28 + 2 days)

  18. Part B: Serum concentrations of neutralizing antibodies

    Serum concentrations of neutralizing antibodies will be determined using a validated analytical procedure.

    Measured: Day -1, Day 7 (pre-am dose) and Follow up (Day 28 + 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start19 Jan 2023
  3. Primary completion20 Apr 2023
  4. Study completion20 Apr 2023

Why it stopped: Closed by Sponsor for business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740280
Sponsor's protocol ID
CV_iCP-NI_002
Status last verified
Sep 2025
First submitted
5 Feb 2023
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing iCP-NI in people with Healthy Volunteers, run by Cellivery Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Closed by Sponsor for business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence and severity of adverse events (AEs) (time frame: Screening to Follow Up (Day 28+2 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05740280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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