HealthyPhase 1NCT02454361
Safety, Tolerability and Pharmacokinetics of KBP-7072
A Phase 1 study testing KBP-7072 in people with Healthy, run by KBP Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KBP-7072
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight subjects in each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).
Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed conditions. The dose tested in Part 2 will be determined based on the safety, tolerability and PK data available from Part 1. Extensive PK samplings will be collected after dosing (pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).
Safety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.
- Conditions
- Healthy
- Being tested
- KBP-7072, Placebo
- Keywords
- Safety, tolerability, pharmacokinetics, KBP-7072
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBP-7072Drug
KBP-7072
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| KBP-7072 cohort 1 | Experimental | KBP-7072 by mouth once Receives: Drug: KBP-7072; Drug: Placebo |
| KBP-7072 cohort 2 | Experimental | KBP-7072 by mouth once Receives: Drug: KBP-7072; Drug: Placebo |
| KBP-7072 cohort 3 | Experimental | KBP-7072 by mouth once Receives: Drug: KBP-7072; Drug: Placebo |
| KBP-7072 cohort 4 | Experimental | KBP-7072 by mouth once Receives: Drug: KBP-7072; Drug: Placebo |
| KBP-7072 cohort 5 | Experimental | KBP-7072 by mouth once Receives: Drug: KBP-7072; Drug: Placebo |
| KBP-7072 Fed Group | Experimental | KBP-7072 by mouth once to the fed group Receives: Drug: KBP-7072 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability (i.e., number of participants with adverse events): predose and postdose
Measured: 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
Measured: 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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBP Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454361
- Sponsor's protocol ID
- KBP7072-1-001
- Status last verified
- Feb 2024
- First submitted
- 18 May 2015
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32071042
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02454361
- Acronym / sponsor ID
- KBP7072-1-001
- Conditions
- Healthy
- Keywords
- Safety, tolerability, pharmacokinetics, KBP-7072
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- KBP BiosciencesIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight subjects in each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).
Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed conditions. The dose tested in Part 2 will be determined based on the safety, tolerability and PK data available from Part 1. Extensive PK samplings will be collected after dosing (pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).
Safety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| KBP-7072 cohort 1 | Experimental | Drug: KBP-7072, Drug: PlaceboKBP-7072 by mouth once |
| KBP-7072 cohort 2 | Experimental | Drug: KBP-7072, Drug: PlaceboKBP-7072 by mouth once |
| KBP-7072 cohort 3 | Experimental | Drug: KBP-7072, Drug: PlaceboKBP-7072 by mouth once |
| KBP-7072 cohort 4 | Experimental | Drug: KBP-7072, Drug: PlaceboKBP-7072 by mouth once |
| KBP-7072 cohort 5 | Experimental | Drug: KBP-7072, Drug: PlaceboKBP-7072 by mouth once |
| KBP-7072 Fed Group | Experimental | Drug: KBP-7072KBP-7072 by mouth once to the fed group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KBP-7072KBP-7072 | Drug | KBP-7072 Fed Group, KBP-7072 cohort 1, KBP-7072 cohort 2, KBP-7072 cohort 3, KBP-7072 cohort 4, KBP-7072 cohort 5 |
| PlaceboPlacebo | Drug | KBP-7072 cohort 1, KBP-7072 cohort 2, KBP-7072 cohort 3, KBP-7072 cohort 4, KBP-7072 cohort 5 |
Primary outcome
The safety and tolerability (i.e., number of participants with adverse events): predose and postdose
Time frame: 10 days
2 secondary outcomes
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
Time frame: 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
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 32071042Huband 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KBP-7072 in people with Healthy, run by KBP Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability (i.e., number of participants with adverse events): predose and postdose (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.