Navigen, Inc started a new clinical trial of A Phase Ia Clinical Study of HIV Entry Inhibitor CPT31: Single Ascending Dose Study of Safety, Tolerability, Immunogenicity, and Pharmacokinetics in Healthy Adults.

The company Navigen, Inc is enrolling patients into the clinical trial investigating A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers.

This first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of the HIV entry inhibitor CPT31 (cholesterol-PIE12-2-trimer) in healthy adults. This is a randomized, placebo-controlled, double-blind, single ascending dose study.

The trial is designed to enroll male and female 18 Years to 55 Years and is being conducted in the Covance Clinical Research Unit Inc, Daytona Beach, Florida, United States.

The study start date is December 7, 2020.

The patients that can be enrolled into this study include:

  • 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 and surgical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and/or Day -1 as assessed by the Investigator (or designee). - Females will not be pregnant or have been within the previous 3 months, or lactating, and females of childbearing potential and males will agree to use contraception. - Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Exclusion Criteria: - 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). - A ≥Grade 2 laboratory abnormality at Screening or Day -1 as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017. - Estimated glomerular filtration rate (eGFR per CKD-Epi equation) of <90 ml/min/1.73 m2. - Known sensitivity to CPT31 or any of its components. - History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). - History of alcoholism or drug/chemical abuse within 2 years prior to Day -1. - Alcohol consumption of > 21 units per week for males and > 14 units 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 positive alcohol breath test result or positive urine drug screen on Day -1. - Positive HIV test as documented by Combo Ag/Ab HIV 1/HIV-2 immunoassay. - Positive hepatitis B surface antigen, positive hepatitis B core antibody with negative hepatitis B surface antibody test result, or positive hepatitis C antibody at Screening or within 3 months before first dose of study treatment. - Participation in a clinical study involving administration of an investigational drug in the past 30 days prior to dosing. - Use or intend to use any prescription or over the counter medications/products (including HIV medications being used for pre-exposure prophylaxis) other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives or acetaminophen up to 2 grams per day for no more than 3 consecutive days within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee). - Use of tobacco or nicotine containing products within 3 months prior to Day -1, or positive cotinine at Screening or Day -1. - Receipt of blood products within 2 months prior to Day -1. - 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. - Have previously completed or withdrawn from this study or any other study investigating CPT31 and have previously received the investigational product. - Subjects who, in the opinion of the Investigator (or designee), should not participate in this study. - Have any clinically significant abnormal ECG results constituting a risk while taking the investigational product, as determined by the Investigator, such as any of the following, as determined by single 12-lead ECG: QT interval corrected for heart rate using Fridericia's method (QTcF) >450 ms for males and >470 ms for females, confirmed by calculating the mean of the original value and 2 repeats; QRS duration >120 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 which would make QTc measurements difficult or QTc data uninterpretable; history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome); risks related to bradycardia, for example, second or third degree atrioventricular block or sick sinus syndrome.

The population that are excluded from participation:

  • 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). - A ≥Grade 2 laboratory abnormality at Screening or Day -1 as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017. - Estimated glomerular filtration rate (eGFR per CKD-Epi equation) of <90 ml/min/1.73 m2. - Known sensitivity to CPT31 or any of its components. - History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). - History of alcoholism or drug/chemical abuse within 2 years prior to Day -1. - Alcohol consumption of > 21 units per week for males and > 14 units 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 positive alcohol breath test result or positive urine drug screen on Day -1. - Positive HIV test as documented by Combo Ag/Ab HIV 1/HIV-2 immunoassay. - Positive hepatitis B surface antigen, positive hepatitis B core antibody with negative hepatitis B surface antibody test result, or positive hepatitis C antibody at Screening or within 3 months before first dose of study treatment. - Participation in a clinical study involving administration of an investigational drug in the past 30 days prior to dosing. - Use or intend to use any prescription or over the counter medications/products (including HIV medications being used for pre-exposure prophylaxis) other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives or acetaminophen up to 2 grams per day for no more than 3 consecutive days within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee). - Use of tobacco or nicotine containing products within 3 months prior to Day -1, or positive cotinine at Screening or Day -1. - Receipt of blood products within 2 months prior to Day -1. - 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. - Have previously completed or withdrawn from this study or any other study investigating CPT31 and have previously received the investigational product. - Subjects who, in the opinion of the Investigator (or designee), should not participate in this study. - Have any clinically significant abnormal ECG results constituting a risk while taking the investigational product, as determined by the Investigator, such as any of the following, as determined by single 12-lead ECG: QT interval corrected for heart rate using Fridericia's method (QTcF) >450 ms for males and >470 ms for females, confirmed by calculating the mean of the original value and 2 repeats; QRS duration >120 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 which would make QTc measurements difficult or QTc data uninterpretable; history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome); risks related to bradycardia, for example, second or third degree atrioventricular block or sick sinus syndrome.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04672083

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