A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers

NCT04672083 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: CPT31-0012U44AI095172-08
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections

Keywords

D-peptide HIV entry inhibitor

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of subjects experiencing serious adverse events (SAEs)

  Check-in (Day -1) through Follow-up (Day 28-30)

Secondary Outcomes (11)

• Cmax

  Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)

• Tmax

  Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)

• T1/2

  Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)

• Area Under the Concentration Curve (AUC) 0-∞

  Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)

• AUC0-tlast

  Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)

Study Arms (4)

Cohort 1

EXPERIMENTAL

6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg) and 2 subjects receiving matching placebo SC injection

Drug: CPT31; Drug: Placebo

Cohort 2

EXPERIMENTAL

6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg) and 2 subjects receiving matching placebo SC injection

Drug: CPT31; Drug: Placebo

Cohort 3

EXPERIMENTAL

6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg) and 2 subjects receiving matching placebo SC injection

Drug: CPT31; Drug: Placebo

Cohort 4

EXPERIMENTAL

6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg) and 2 subjects receiving matching placebo SC injection

Drug: CPT31; Drug: Placebo

Interventions

CPT31 DRUG

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

Also known as: cholesterol-PIE12-2-trimer, cholesterol-PIE12-trimer

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

matching placebo

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navigen, Inc.: lead
• Covance: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Covance Clinical Research Unit Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Alan L. Mueller, VP Research
• Organization: Navigen, Inc.

amueller@nvgn.com

801-243-9703

Study Officials

• Alan L Mueller, PhD

  Navigen, Inc.

  STUDY DIRECTOR

• Hugh A Coleman, DO

  Covance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: November 16, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 29, 2021
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)