A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: CPT31; Placebo
Intervention description: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer; matching placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: D-peptide HIV entry inhibitor

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 randomized, placebo-controlled, double-blind, single ascending dose study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 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.