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Completed

NCT Number: NCT02654626

A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects

This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Frontage Laboratories, Inc.

Secaucus, New Jersey, 07094, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female subject
  • Are between the ages of 18 and 55 years (inclusive);
  • Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.

Exclusion criteria

  • Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
  • Known or suspected malignancy;
  • Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
  • Positive pregnancy test result.

Treatment and study plan

KBP-7072

Drug

Drug Intervention

Placebo

Other

Primary outcomes

  1. Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects

    Time frame: up to 17 days

Secondary outcomes

  1. Area Under Curve (AUC) in healthy subjects

    Time frame: up to 10 days

    on Day 1 (first dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours post dose; on Days 4, 7, 8, and 9: pre-dose (within 30 minutes prior to dosing); on Day 10 (last dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.

Sponsors and collaborators

Lead sponsor

KBP Biosciences

Industry

Registry information

Official study title

A Randomized, Single-blind, Placebo-controlled, Sequential Parallel-Group and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2016
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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