Healthy SubjectsPhase 1NCT05507463
Study of KBP-7072 in Healthy Male and Female Subjects
A Phase 1 study testing KBP-7072 in people with Healthy Subjects, run by KBP Biosciences at 1 site in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- KBP-7072
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 29 Jun 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18 and 30 kg/m2 at the time of screening
- In good health, determined b no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements and clinical laboratory evaluations
- Females of nonchildbearing potential defined as permanently sterile or postmenopausal.
- Males will agree to use contraception.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine or psychiatric disorder as determined by the investigator.
- Abnormal results of ophthalmologic examination within 3 months prior to dosing self-reported by subject.
- Supine systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
- Triglycerides > 200 mg/dL
- Total cholesterol > 240 mg/dL or LDL >190 mg/dL or HDL < 40 mg/dL
- Positive urine drug screen at screening or check-in or positive blood alcohol test result at check-in.
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- Positive hepatitis panel and/or positive HIV test
- Administration of a Covid-19 vaccine in the past 28 days prior to dosing
- Interpretation of liver ultrasound with presence of fatty liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International - Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase I, Double-blind, Placebo-controlled, Single and Multiple Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study of KBP-7072 in Healthy Male and Female Subjects
This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-in on Day -1 (the day before dosing) to discharge on Day 8. In Part A, serial blood and urine collections will be obtained on Day 1 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings. Part B (MAD) will comprise an ascending multiple dose, sequential group study. Each subject will participate on one treatment period only and reside at the study site from check-in on Day -1 until discharge on Day 17. In Part B, serial blood and urine collections will be obtained on Day 1 pre-dose through 24 hours post start of infusion and on Day 10 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Trough blood sample collections for analysis of plasma concentrations of KBP-7072 and KBP-6079 will be obtained pre-dose on Days 3, 4, 5, 6, 7, 8 and 9. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings.
- Conditions
- Healthy Subjects
- Being tested
- KBP-7072, Placebo
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 | Experimental | Proposed dose levels for Part A: 25, 50, 100, 150 and 200mg KBP-7072. Proposed dose levels for Part B: 50 and 100mg. Administration route is intravenous infusion. Receives: Drug: KBP-7072 |
| Placebo | Placebo comparator | Placebo for intravenous infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
Measured: Time Frame: SAD 1- 7 days and MAD 1-17 days
Secondary outcomes (8)
Pharmacokinetics Parameters :AUC from time 0 extrapolated to infinity (AUC0-∞)
AUC from time 0 extrapolated to infinity (AUC0-∞)
Measured: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast),
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Measured: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-τ), from time zero to time of last quantifiable concentration (AUC0-tlast)from time zero to time of last quantifiable concentration (AUC0-tlast)
AUC over a dosing interval (AUC0-τ) - Plasma
Measured: MAD samples will be collected on Day 1 pre-dose and at 5, 15, 30, 45 minutes, and at 1, 1.5, 2, 4, 6, 10, 12, 24 (Day 2) hours, pre-dose samples at 48 (Day 3), 72 (Day 4), 96 (Da
Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax) - Plasma
Measured: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax)
Time of the maximum observed plasma concentration (Tmax) - Plasma
Measured: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2)
Apparent terminal elimination half-life (t1/2) - Plasma
Measured: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168(Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: observed accumulation ratio based on AUC0-τ (ARAUC0-τ)
Observed accumulation ratio based on AUC0-τ (ARAUC0-τ) - Plasma
Measured: MAD samples will be collected on Day 1 pre-dose and at 5, 15, 30, 45 minutes, and at 1, 1.5, 2, 4, 6, 10, 12, 24 (Day 2) hours, pre-dose samples at 48 (Day 3), 72 (Day 4), 96 (Da
Pharmacokinetics Parameters: amount of drug excreted in urine (Ae)
Amount of drug excreted in urine (Ae) - Urine
Measured: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168(Day 8) hour(s) post start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start16 Aug 2022
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBP Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Ronald Goldwater, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507463
- Sponsor's protocol ID
- KBP7072-1-004
- Status last verified
- Feb 2024
- First submitted
- 24 Jun 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 Phase I, Double-blind, Placebo-controlled, Single and Multiple Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study of KBP-7072 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05507463
- Acronym / sponsor ID
- KBP7072-1-004
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- KBP BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- 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 double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-in on Day -1 (the day before dosing) to discharge on Day 8. In Part A, serial blood and urine collections will be obtained on Day 1 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings. Part B (MAD) will comprise an ascending multiple dose, sequential group study. Each subject will participate on one treatment period only and reside at the study site from check-in on Day -1 until discharge on Day 17. In Part B, serial blood and urine collections will be obtained on Day 1 pre-dose through 24 hours post start of infusion and on Day 10 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Trough blood sample collections for analysis of plasma concentrations of KBP-7072 and KBP-6079 will be obtained pre-dose on Days 3, 4, 5, 6, 7, 8 and 9. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KBP-7072 | Experimental | Drug: KBP-7072Proposed dose levels for Part A: 25, 50, 100, 150 and 200mg KBP-7072. Proposed dose levels for Part B: 50 and 100mg. Administration route is intravenous infusion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for intravenous infusion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI between 18 and 30 kg/m2 at the time of screening
- In good health, determined b no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements and clinical laboratory evaluations
- Females of nonchildbearing potential defined as permanently sterile or postmenopausal.
- Males will agree to use contraception.
Key exclusion criteria (9 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine or psychiatric disorder as determined by the investigator.
- Abnormal results of ophthalmologic examination within 3 months prior to dosing self-reported by subject.
- Supine systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
- Triglycerides > 200 mg/dL
- Total cholesterol > 240 mg/dL or LDL >190 mg/dL or HDL < 40 mg/dL
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 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Time frame: Time Frame: SAD 1- 7 days and MAD 1-17 days
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
8 secondary outcomes
Pharmacokinetics Parameters :AUC from time 0 extrapolated to infinity (AUC0-∞)
Time frame: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast),
Time frame: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-τ), from time zero to time of last quantifiable concentration (AUC0-tlast)from time zero to time of last quantifiable concentration (AUC0-tlast)
Time frame: MAD samples will be collected on Day 1 pre-dose and at 5, 15, 30, 45 minutes, and at 1, 1.5, 2, 4, 6, 10, 12, 24 (Day 2) hours, pre-dose samples at 48 (Day 3), 72 (Day 4), 96 (Da
Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax)
Time frame: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax)
Time frame: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2)
Time frame: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168(Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: observed accumulation ratio based on AUC0-τ (ARAUC0-τ)
Time frame: MAD samples will be collected on Day 1 pre-dose and at 5, 15, 30, 45 minutes, and at 1, 1.5, 2, 4, 6, 10, 12, 24 (Day 2) hours, pre-dose samples at 48 (Day 3), 72 (Day 4), 96 (Da
Pharmacokinetics Parameters: amount of drug excreted in urine (Ae)
Time frame: SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168(Day 8) hour(s) post start of infusion
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.
- Individual participant dataSharing planned: No
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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.
Ronald Goldwater principal investigator
Parexel
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 Subjects, 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 4 inclusion and 9 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. Some participants in this study may receive a placebo. 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?
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations (time frame: Time Frame: SAD 1- 7 days and MAD 1-17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.