Bacterial InfectionsPhase 1NCT05226923
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
A Phase 1 study testing KSP-1007 and Meropenem in people with Bacterial Infections, run by Sumitovant Biopharma, Inc. at 1 site in United States.
Trial summary
This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- KSP-1007 and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 1 Oct 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects 18 to 55 years of age, inclusive
- Females that engage in heterosexual activity must agree to use a highly selective birth control (BC) method (< 1% failure rate per year) throughout the study, or have a documented reproductive status of non-childbearing based on medical history, or is postmenopausal
- Males that engage in heterosexual activity that has the risk of pregnancy must agree to use effective BC and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication
- Body mass index (BMI) 2: 18 kg/m2 and :s 32 kg/m2
Who cannot join
- History of Gilbert's Syndrome
- History of severe allergic reactions to β-lactams or β-lactamase inhibitors or a history allergic reactions to multiple medications.
- Pregnant female, determined by positive serum or urine human chorionic gonadotropin pregnancy test at Screening, or prior to dosing
- Lactating female
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of > 499 mL within 56 days prior to Day 1
- Participation in a study with an investigational drug or device study with last dose of investigational drug within 30 days (90 days if the study involved a biologic, cellular, or vaccine product) or 5 half-lives, whichever is longer, before study treatment administration
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- Subjects with abnormal hepatic and/or renal function, that could interfere with the metabolism, and/or excretion of the study treatments
- Abnormal blood pressure, either low (defined as < 90 mmHg systolic and/ or < 45 mmHg diastolic) or high (defined as > 140 mmHg systolic and/ or > 90 mmHg diastolic) at Screening
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV at Screening. Subjects who test positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) also will be ineligible. Evidence of prior HBV vaccination (positive hepatitis B surface antibody [HBsAb)) is not exclusionary.
- Subjects unable to abstain from alcohol for 48 hours prior to admission through to completion of the Follow-up visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
Read the detailed description
Carbapenem-resistant Gram-negative bacteria are responsible for serious, life-threatening infections and are regarded as an urgent threat by the Centers for Disease Control and Prevention and the World Health Organizations. One principal mechanism of carbapenem resistance is bacterial production of carbapenemases, which reduce the effectiveness of meropenem and other carbapenem class antibiotics. Sumitovant Biopharma is developing a fixed combination of meropenem and KSP-1007 for the treatment of serious bacterial infections.
- Conditions
- Bacterial Infections
- Being tested
- KSP-1007, Placebo:0.9% sodium chloride, Meropenem
- Keywords
- Bacterial Disease, Bacterial Infection, Bacterial Infections, Bacterial, Healthy Volunteers
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSP-1007Drug
Single and multiple doses, intravenous administration
Placebo:0.9% sodium chlorideOther
Single and multiple doses, intravenous administration
MeropenemDrug
Multiple doses, intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| KSP-1007 single ascending dose | Experimental | Single, ascending intravenous dose of KSP-1007 Receives: Drug: KSP-1007 |
| Placebo single dose | Placebo comparator | Single dose of placebo (0.9% normal saline) Receives: Other: Placebo:0.9% sodium chloride |
| KSP-1007 multiple ascending dose | Experimental | Multiple, ascending, intravenous doses of KSP-1007 Receives: Drug: KSP-1007 |
| Placebo multiple dose | Placebo comparator | Multiple doses of placebo (0.9% saline) Receives: Other: Placebo:0.9% sodium chloride |
| KSP-1007 multiple ascending dose + Meropenem multiple dose | Experimental | Multiple, ascending intravenous doses of KSP-1007 and multiple doses of meropenem (fixed dose) Receives: Drug: KSP-1007; Drug: Meropenem |
| Placebo + Meropenem multiple dose | Placebo comparator | Multiple doses of placebo (0.9% normal saline) plus multiple doses of meropenem (fixed dose) Receives: Other: Placebo:0.9% sodium chloride; Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events assessed by subject .
Incidence of adverse events
Measured: up to Day 14
Secondary outcomes (9)
Peak plasma concentration of KSP-1007
The plasma concentration of KSP-1007 will be measured over time, and the peak plasma concentration, or Cmax, of KSP-1007 will be determined
Measured: Up to 5 days after dosing
Plasma concentration of KSP-1007 versus time curve
The plasma concentration of KSP-1007 will be measured over time and the area under the curve, or AUC, of KSP-1007 will be determined
Measured: Up to 5 days after dosing
Cumulative amount of KSP-1007 excreted in urine over time
Total amount of unchanged drug excreted in urine over a dosing interval
Measured: Up to 5 days after start of dosing
Renal clearance of KSP-1007 in urine over time
Renal clearance in urine. Urine was collected up to 5 days after dosing.
Measured: Up to 5 days after start of dosing
Peak plasma concentration of meropenem
The plasma concentration of meropenem will be measured over time, and the peak plasma concentration, or Cmax, of meropenem will be determined
Measured: Up to 5 days after start of dosing
Plasma concentration versus time curve of meropenem
The plasma concentration of meropenem will be measured over time and the area under the curve, or AUC, of meropenem will be determined
Measured: Up to 5 days after start of dosing
Cumulative amount of meropenem excreted in urine over time
Total amount of unchanged drug excreted in urine over a dosing interval.
Measured: Up to 5 days after start of dosing
Renal clearance of meropenem in urine over time
Renal clearance in urine. Urine was collected up to 5 days after dosing.
Measured: Up to 5 days after start of dosing
ECG QTcF interval
Change from baseline QTcF interval
Measured: 24 hours after start of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start12 Jan 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitovant Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hayes Dansky, M.D., Study director, Sumitovant Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226923
- Sponsor's protocol ID
- KSP-1007-101
- Status last verified
- Oct 2022
- First submitted
- 7 Jan 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05226923
- Acronym / sponsor ID
- KSP-1007-101
- Conditions
- Bacterial Infections
- Keywords
- Bacterial Disease, Bacterial Infection, Bacterial Infections, Bacterial, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Sumitovant Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Feb 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 study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
Detailed description
Carbapenem-resistant Gram-negative bacteria are responsible for serious, life-threatening infections and are regarded as an urgent threat by the Centers for Disease Control and Prevention and the World Health Organizations. One principal mechanism of carbapenem resistance is bacterial production of carbapenemases, which reduce the effectiveness of meropenem and other carbapenem class antibiotics. Sumitovant Biopharma is developing a fixed combination of meropenem and KSP-1007 for the treatment of serious bacterial infections.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| KSP-1007 single ascending dose | Experimental | Drug: KSP-1007Single, ascending intravenous dose of KSP-1007 |
| Placebo single dose | Placebo comparator | Other: Placebo:0.9% sodium chlorideSingle dose of placebo (0.9% normal saline) |
| KSP-1007 multiple ascending dose | Experimental | Drug: KSP-1007Multiple, ascending, intravenous doses of KSP-1007 |
| Placebo multiple dose | Placebo comparator | Other: Placebo:0.9% sodium chlorideMultiple doses of placebo (0.9% saline) |
| KSP-1007 multiple ascending dose + Meropenem multiple dose | Experimental | Drug: KSP-1007, Drug: MeropenemMultiple, ascending intravenous doses of KSP-1007 and multiple doses of meropenem (fixed dose) |
| Placebo + Meropenem multiple dose | Placebo comparator | Other: Placebo:0.9% sodium chloride, Drug: MeropenemMultiple doses of placebo (0.9% normal saline) plus multiple doses of meropenem (fixed dose) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects 18 to 55 years of age, inclusive
- Females that engage in heterosexual activity must agree to use a highly selective birth control (BC) method (< 1% failure rate per year) throughout the study, or have a documented reproductive status of non-childbearing based on medical history, or is postmenopausal
- Males that engage in heterosexual activity that has the risk of pregnancy must agree to use effective BC and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication
- Body mass index (BMI) 2: 18 kg/m2 and :s 32 kg/m2
Key exclusion criteria (10 listed)
- History of Gilbert's Syndrome
- History of severe allergic reactions to β-lactams or β-lactamase inhibitors or a history allergic reactions to multiple medications.
- Pregnant female, determined by positive serum or urine human chorionic gonadotropin pregnancy test at Screening, or prior to dosing
- Lactating female
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of > 499 mL within 56 days prior to Day 1
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 |
|---|---|---|
| KSP-1007Single and multiple doses, intravenous administration | Drug | KSP-1007 multiple ascending dose, KSP-1007 multiple ascending dose + Meropenem multiple dose, KSP-1007 single ascending dose |
| Placebo:0.9% sodium chlorideSingle and multiple doses, intravenous administration | Other | Placebo + Meropenem multiple dose, Placebo multiple dose, Placebo single dose |
| MeropenemMultiple doses, intravenous administration | Drug | KSP-1007 multiple ascending dose + Meropenem multiple dose, Placebo + Meropenem multiple dose |
Primary outcome
Incidence of adverse events assessed by subject .
Time frame: up to Day 14
Incidence of adverse events
9 secondary outcomes
Peak plasma concentration of KSP-1007
Time frame: Up to 5 days after dosing
Plasma concentration of KSP-1007 versus time curve
Time frame: Up to 5 days after dosing
Cumulative amount of KSP-1007 excreted in urine over time
Time frame: Up to 5 days after start of dosing
Renal clearance of KSP-1007 in urine over time
Time frame: Up to 5 days after start of dosing
Peak plasma concentration of meropenem
Time frame: Up to 5 days after start of dosing
Plasma concentration versus time curve of meropenem
Time frame: Up to 5 days after start of dosing
Cumulative amount of meropenem excreted in urine over time
Time frame: Up to 5 days after start of dosing
Renal clearance of meropenem in urine over time
Time frame: Up to 5 days after start of dosing
ECG QTcF interval
Time frame: 24 hours after start of dosing
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 27 Oct 2022.
- 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.
Hayes Dansky, M.D. study director
Sumitovant Biopharma, Inc.
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 KSP-1007 and Meropenem in people with Bacterial Infections, run by Sumitovant Biopharma, Inc. 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 10 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 27 Oct 2022. 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?
Incidence of adverse events assessed by subject . (time frame: up to Day 14). 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 27 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.