Early safety test of iCP-NI drug halted before completion
NCT ID NCT05740280
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase study tested the safety and tolerability of an experimental drug called iCP-NI in 24 healthy adults. Participants received either the drug or a placebo by intravenous infusion. The trial was terminated, so no conclusions about effectiveness can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iCP-NI (improved cell-permeable nuclear import inhibitor)
- What could go wrong
- This was an early safety study in healthy people, so it cannot show if the drug works for any disease. The trial was terminated, meaning results may be incomplete.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jan 2023
- Finished
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Apr 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Labcorp Clinical Research Unit Inc.
Daytona Beach, Florida, 32117, United States
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