Safety, Tolerability and Pharmacokinetics of KBP-7072
A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 Following Oral Administration
1 other identifier
interventional
46
1 country
1
Brief Summary
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2015
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 23, 2024
February 1, 2024
5 months
May 18, 2015
February 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety and tolerability (i.e., number of participants with adverse events): predose and postdose
10 days
Secondary Outcomes (2)
Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose
10 days
Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose among participants who have had food
10 days
Study Arms (6)
KBP-7072 cohort 1
EXPERIMENTALKBP-7072 by mouth once
KBP-7072 cohort 2
EXPERIMENTALKBP-7072 by mouth once
KBP-7072 cohort 3
EXPERIMENTALKBP-7072 by mouth once
KBP-7072 cohort 4
EXPERIMENTALKBP-7072 by mouth once
KBP-7072 cohort 5
EXPERIMENTALKBP-7072 by mouth once
KBP-7072 Fed Group
EXPERIMENTALKBP-7072 by mouth once to the fed group
Interventions
Eligibility Criteria
You may qualify if:
- males and surgically sterile or postmenopausal females
- aged between 18-45 years
- body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2,
- no significant medical history
- normal renal function
- good general health
You may not qualify if:
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KBP Bioscienceslead
Study Sites (1)
KBP
Princeton, New Jersey, 08540, United States
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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
May 27, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
February 23, 2024
Record last verified: 2024-02