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

Sponsor
KBP Biosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02654626
Collaborator
(none)
16
Enrollment
1
Location
4
Arms
2
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

Outcome Measures

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 [up to 17 days]

Secondary Outcome Measures

  1. Area Under Curve (AUC) in healthy subjects [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Frontage Laboratories, Inc. Secaucus New Jersey United States 07094

Sponsors and Collaborators

  • KBP Biosciences

Investigators

  • Study Director: Bin Zhang, KBP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KBP Biosciences
ClinicalTrials.gov Identifier:
NCT02654626
Other Study ID Numbers:
  • KBP7072-1-002
First Posted:
Jan 13, 2016
Last Update Posted:
May 17, 2016
Last Verified:
May 1, 2016

Study Results

No Results Posted as of May 17, 2016