Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05740280
Other study ID # CV_iCP-NI_002
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date January 19, 2023
Est. completion date August 17, 2023

Study information

Verified date May 2023
Source Cellivery Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 64
Est. completion date August 17, 2023
Est. primary completion date August 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 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. Exclusion Criteria: 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: 1. QTcF >450 ms in males or >470 ms in females, confirmed by calculating the mean of the original value and 2 repeats. 2. QRS duration >110 ms, confirmed by calculating the mean of the original value and 2 repeats 3. PR interval >220 ms, confirmed by calculating the mean of the original value and 2 repeats. 4. findings that would make QTc measurements difficult or QTc data uninterpretable. 5. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
iCP-NI
20 mg/mL iCP-NI solution for intravenous injection
Placebo
Placebo solution for intravenous injection

Locations

Country Name City State
United States Labcorp Clinical Research Unit Inc. Daytona Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
Cellivery Therapeutics, Inc. Labcorp Corporation of America Holdings, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Incidence and severity of adverse events (AEs) Screening to Follow Up (Day 28+2 days)
Primary Part B: Incidence and severity of adverse events (AEs) Screening to Follow Up (Day 28+2 days)
Primary Part A: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results Screening to Follow Up (Day 7)
Primary Part B: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results Screening to Follow Up (Day 28+2 days)
Primary Part A: Number of participants with abnormal 12-lead ECG parameters Screening to Follow Up (Day 7)
Primary Part B: Number of participants with abnormal 12-lead ECG parameters Screening to Follow Up (Day 28+2 days)
Primary Part A: Number of participants with abnormal vital signs measurements Screening to Follow Up (Day 7)
Primary Part B: Number of participants with abnormal vital signs measurements Screening to Follow Up (Day 28+2 days)
Primary Part A: Number of participants with abnormal physical examinations Screening to Follow Up (Day 7)
Primary Part B: Number of participants with abnormal physical examinations Screening to Follow Up (Day 28+2 days)
Secondary Part A: Pharmacokinetics (PK): Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-8) of iCP-NI Day 1: Pre-dose up to 12 hours post start of infusion
Secondary Part B: Pharmacokinetics (PK): Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-8) of iCP-NI Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)
Secondary 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
Secondary 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)
Secondary Part A: Pharmacokinetics (PK): Area under the concentration-time curve over a dosing interval (t) (AUC0-t) of iCP-NI Day 1: Pre-dose up to 12 hours post start of infusion
Secondary Part B: Pharmacokinetics (PK): Area under the concentration-time curve over a dosing interval (t) (AUC0-t) of iCP-NI Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)
Secondary Part A: Pharmacokinetics (PK): Maximum observed concentration (Cmax) of iCP-NI Day 1: Pre-dose up to 12 hours post start of infusion
Secondary Part B: Pharmacokinetics (PK): Maximum observed concentration (Cmax) of iCP-NI Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)
Secondary Part A: Pharmacokinetics (PK): Time of the maximum observed concentration (tmax) of iCP-NI Day 1: Pre-dose up to 12 hours post start of infusion
Secondary Part B: Pharmacokinetics (PK): Time of the maximum observed concentration (tmax) of iCP-NI Day 1 (pre-dose) up to Day 7 (12 hours post start of infusion)
Secondary Part A: Pharmacokinetics (PK): Apparent terminal elimination half life (t1/2) of iCP-NI Day 1: Pre-dose up to 12 hours post start of infusion
Secondary Part B: Pharmacokinetics (PK): Apparent terminal elimination half life (t1/2) of iCP-NI Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)
Secondary Part A: Pharmacokinetics (PK): Accumulation ratio based on AUC0-t (ARAUC) of iCP-NI Day 1: Pre-dose up to 12 hours post start of infusion
Secondary Part B: Pharmacokinetics (PK): Accumulation ratio based on AUC0-t (ARAUC) of iCP-NI Day 1 (Pre-dose) up to Day 7 (12 hours post start of infusion)
Secondary Part A: Serum concentrations of anti-iCP-NI antibodies Serum concentrations of anti-iCP-NI antibodies will be determined using a validated analytical procedure. Day -1, Follow up (Day 7) and Immunogenicity Visit (Day 28 + 2 days)
Secondary Part B: Serum concentrations of anti-iCP-NI antibodies Serum concentrations of anti-iCP-NI antibodies will be determined using a validated analytical procedure. Day -1, Day 7 (pre-am dose) and Follow up (Day 28 + 2 days)
Secondary Part A: Serum concentrations of neutralizing antibodies Serum concentrations of neutralizing antibodies will be determined using a validated analytical procedure. Day -1, Follow up (Day 7) and Immunogenicity Visit (Day 28 + 2 days)
Secondary Part B: Serum concentrations of neutralizing antibodies Serum concentrations of neutralizing antibodies will be determined using a validated analytical procedure. Day -1, Day 7 (pre-am dose) and Follow up (Day 28 + 2 days)
See also
  Status Clinical Trial Phase
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1