A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers

• Status: Enrolling by invitation
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Navigen, Inc.
• Collaborators: Covance; National Institute of Allergy and Infectious Diseases (NIAID)

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 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.