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

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ClinicalTrials.gov Identifier: NCT02654626
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
KBP Biosciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: KBP-7072 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: KBP-7072: Cohort 1
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
Drug: KBP-7072
Drug Intervention

Other: Placebo
Experimental: KBP-7072: Cohort 2
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
Drug: KBP-7072
Drug Intervention

Other: Placebo
Experimental: KBP-7072: Cohort 3
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
Drug: KBP-7072
Drug Intervention

Other: Placebo
Experimental: KBP-7072: Cohort 4
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
Drug: KBP-7072
Drug Intervention

Other: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654626


Locations
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United States, New Jersey
Frontage Laboratories, Inc.
Secaucus, New Jersey, United States, 07094
Sponsors and Collaborators
KBP Biosciences
Investigators
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Study Director: Bin Zhang KBP

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Responsible Party: KBP Biosciences
ClinicalTrials.gov Identifier: NCT02654626     History of Changes
Other Study ID Numbers: KBP7072-1-002
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016