NCT02654626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 8, 2016

Last Update Submit

February 21, 2024

Conditions

Healthy

Outcome Measures

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

    up to 17 days

Secondary Outcomes (1)

  • Area Under Curve (AUC) in healthy subjects

    up to 10 days

Study Arms (4)

KBP-7072: Cohort 1

EXPERIMENTAL

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Drug: KBP-7072Other: Placebo

KBP-7072: Cohort 2

EXPERIMENTAL

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Drug: KBP-7072Other: Placebo

KBP-7072: Cohort 3

EXPERIMENTAL

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Drug: KBP-7072Other: Placebo

KBP-7072: Cohort 4

EXPERIMENTAL

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Drug: KBP-7072Other: Placebo

Interventions

KBP-7072DRUG

Drug Intervention

KBP-7072: Cohort 1KBP-7072: Cohort 2KBP-7072: Cohort 3KBP-7072: Cohort 4
PlaceboOTHER
KBP-7072: Cohort 1KBP-7072: Cohort 2KBP-7072: Cohort 3KBP-7072: Cohort 4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frontage Laboratories, Inc.

Secaucus, New Jersey, 07094, United States

Location

Related Publications (1)

  • Huband MD, Mendes RE, Pfaller MA, Lindley JM, Strand GJ, Benn VJ, Zhang J, Li L, Zhang M, Tan X, Liu Q, Flamm RK. In Vitro Activity of KBP-7072, a Novel Third-Generation Tetracycline, against 531 Recent Geographically Diverse and Molecularly Characterized Acinetobacter baumannii Species Complex Isolates. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02375-19. doi: 10.1128/AAC.02375-19. Print 2020 Apr 21.

    PMID: 32071042DERIVED

MeSH Terms

Interventions

kbp-7072

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 13, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

US(1)