Status:
COMPLETED
A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
Lead Sponsor:
Navigen, Inc.
Collaborating Sponsors:
Covance
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 random...
Detailed Description
This is a single subcutaneous (SC) dose study. Doses will be administered in an escalating manner following satisfactory review by a Protocol Safety Review Team (PSRT) of the safety, tolerability and ...
Eligibility Criteria
Inclusion
- 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 Informed Consent Form (ICF) and to abide by the study restrictions.
Exclusion
- 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.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04672083
Start Date
November 16 2020
End Date
April 29 2021
Last Update
February 21 2023
Active Locations (1)
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1
Covance Clinical Research Unit Inc.
Daytona Beach, Florida, United States, 32117