A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects

NCT04481594 | Unknown Phase 1 FDA Drug

• 1 other identifier: HPN-01-US-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (9)

• Single-dose PK Parameter

  Cmax of HPN-01

  Up to 72 hours postdose

• Single-dose PK Parameter

  AUClast of HPN-01

  Up to 72 hours postdose

• Single-dose PK Parameter

  AUCinf of HPN-01

  Up to 72 hours postdose

• Multiple-dose PK Parameters

  Cmax of HPN-01

  Up to 24 hours postdose

• Multiple-dose PK Parameters

  Ctau of HPN-01

  Up to 24 hours postdose

• Multiple-dose PK Parameters

  AUCtau of HPN-01

  Up to 24 hours postdose

• Incidence of Adverse Events

  Up to 15 days plus 6 days

• Proportion of Participants with 12-lead ECG Abnormalities

  Up to 15 days plus 6 days

• Proportion of Participants with Clinical Laboratory Abnormalities

  Up to 15 days plus 6 days

Secondary Outcomes (2)

• Measurement of PD Biomarker Level of Fibroblast Growth Factor 19 (FGF19) Following Oral Single and Multiple Ascending Dose Administration

  Up to 24 hours postdose

• Measurement of PD Biomarker Level of C4 Following Oral Single and Multiple Ascending Dose Administration

  Up to 24 hours postdose

Study Arms (2)

HPN-01

EXPERIMENTAL

Part 1: Including 6 dose cohorts (25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg). Each dose cohort will receive a single dose of HPN-01. One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01. Part 2: Including 3 dose cohorts (50 mg, 100 mg and 200 mg). Each dose cohort will receive HPN-01 once daily for a consecutive 14 days.

Drug: HPN-01

Placebo

PLACEBO COMPARATOR

Part 1: Including 6 dose cohorts (25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg). Each dose cohort will receive a single dose of HPN-01 placebo. Part 2: Including 3 dose cohorts (50 mg, 100 mg and 200 mg). Each dose cohort will receive HPN-01 placebo once daily for a consecutive 14 days.

Drug: Placebo

Interventions

HPN-01 DRUG

25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 capsules

HPN-01

Placebo DRUG

25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 placebo capsules

Placebo

Eligibility Criteria

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

You may qualify if:

• Are capable of giving informed consent and complying with study procedures;
• Are between the ages of 18 and 55 years, inclusive;
• Female subjects have a negative pregnancy test result at screening and admission to the study site, and meet one of the following criteria:
• Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) \[e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)\]
• Surgically sterile for at least 3 months prior to screening by one of the following means:
• Bilateral tubal ligation
• Bilateral salpingectomy (with or without oophorectomy)
• Surgical hysterectomy
• Bilateral oophorectomy (with or without hysterectomy)
• Postmenopausal, defined as the following:
• Last menstrual period greater than 12 months prior to screening
• Postmenopausal status confirmed by serum FSH and estradiol levels at screening;
• Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
• Normal renal function (eGFR \> 90 ml/min/1.75 m2) as determined by Investigator following review of clinical laboratory test results;
• Non-smoker and has not been exposed to any products containing nicotine in the last 6 months;

You may not qualify if:

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
• Known or suspected malignancy;
• Reported history of pancreatitis or gall stones;
• Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
• Family history of long QTc syndrome;
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
• Poor venous access;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgG and IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening;
• Donated or lost \>500 mL of blood in the previous 3 months prior to screening;
• Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives) prior to first dose of study drug, whichever is longer;
• Taken any prescription medications (with the exception of hormonal contraceptive) within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
• Hospital admission or major surgery within 6 months prior to screening;
• A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
• A history of alcohol abuse according to medical history (≥ 2 drinks per day for male and ≥ 1 drink per day for female) within 9 months prior to screening;
• A positive screen for alcohol, drugs of abuse at screening or admission;

Sponsors & Collaborators

• Hepanova Inc.: lead

Study Sites (1)

Frontage Clinical Services, Inc

Secaucus, New Jersey, 07094, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Michelle Pluviose, MS

CONTACT

201-416-7763; mpluviose@frontagelab.com

Annie Li, MD

CONTACT

201-416-7770; ali@frontagelab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind (participant, investigator)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 22, 2020
• Study Start: September 8, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)