Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)Phase 1NCT02439359
A Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects
A Phase 1 study testing CF-301 in people with Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia), run by ContraFect at 2 sites in United States.
Trial summary
A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
- What is being tested?
- CF-301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a healthy male of any race or ethnicity, at least 18 years of age and no more than 55 years of age, inclusively, OR
- Be a healthy female of any race or ethnicity of non-childbearing potential between 18 and 55 years of age, inclusive. OR
- Be a healthy non-pregnant, non-lactating female of any race or ethnicity of childbearing potential between 18 and 55 years of age,
- Contraception in use for at least 60 days prior to the Screening visit,
- Have a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
- Have no significant diseases in the opinion of the Investigator in the medical history or clinically significant findings on physical examination or clinical laboratory evaluations.
Who cannot join
- Any disease or condition in the opinion of the Investigator that might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- The presence of clinically significant laboratory values that are out of the normal range.
- Subjects with an aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), alkaline phosphatase, bilirubin, blood urea nitrogen (BUN), creatinine, prothrombin time (PT), or activated partial thromboplastin time (aPTT) > 5% above the upper limit of normal, or hemoglobin or hematocrit level < 5% below the lower limit of normal may not be enrolled.
- A history of alcoholism or drug addiction, or illicit drug use within the past 2 years, or positive results from a urine screen for substances of abuse.
- Has smoked within 28 days prior to receiving study drug or has a positive urine test for cotinine.
- A history of serious mental illness.
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- A history of difficulty donating blood or inadequate venous access.
- The donation of blood or plasma within 28 days prior to receiving study drug.
- A positive hepatitis screen that tests for both hepatitis B surface antigen (HBsAg) and antibody to hepatitis C virus (HCVAb).
- A positive test result for human immunodeficiency virus (HIV) antibody by enzyme immunoassay, which is confirmed by Western blot.
- Use of an investigational drug or product, or participation in a drug study within a period of 28 days prior to receiving study drug (for investigational drugs with an elimination half-life greater than 10 days, this will be extended to 60 days).
- Use of any prescription or over-the-counter (OTC) drug therapy, including herbal, homeopathic, vitamins, minerals and nutritional supplements, within 2 weeks prior to receiving the study drug contraceptives in women of childbearing potential is allowed during the study.
- If a subject taking prescription drug therapy for chronic diseases, but that prescription is stopped in order to qualify for the study, the subject should not be enrolled in the study.
- Use of any drug therapy (ie, prescription drugs, over-the counter products, herbal and vitamin products) known to induce or inhibit cytochrome P450 hepatic enzymes responsible for drug metabolism within 28 days prior to receiving study drug or during the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Lenexa, Kansas, 66219
Cf 301-105
Omaha, Nebraska
About this study
Official title: A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Male and Female Subjects
A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects.
- Being tested
- CF-301, Placebo
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF-301Drug
Dose escalation
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| CF-301 | Experimental | CF-301 Receives: Drug: CF-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by AE's
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)Studies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContraFect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439359
- Sponsor's protocol ID
- CF 301-101
- Status last verified
- Dec 2016
- First submitted
- 27 Apr 2015
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Public Presentation at ECCMID April 2016
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02439359
- Acronym / sponsor ID
- CF 301-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ContraFectIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 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.
A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| CF-301 | Experimental | Drug: CF-301CF-301 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be a healthy male of any race or ethnicity, at least 18 years of age and no more than 55 years of age, inclusively, OR
- Be a healthy female of any race or ethnicity of non-childbearing potential between 18 and 55 years of age, inclusive. OR
- Be a healthy non-pregnant, non-lactating female of any race or ethnicity of childbearing potential between 18 and 55 years of age,
- Contraception in use for at least 60 days prior to the Screening visit,
- Have a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
Key exclusion criteria (14 listed)
- Any disease or condition in the opinion of the Investigator that might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- The presence of clinically significant laboratory values that are out of the normal range.
- A history of alcoholism or drug addiction, or illicit drug use within the past 2 years, or positive results from a urine screen for substances of abuse.
- Has smoked within 28 days prior to receiving study drug or has a positive urine test for cotinine.
- A history of serious mental illness.
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 |
|---|---|---|
| CF-301Dose escalation | Drug | CF-301 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability as measured by AE's
Time frame: up to 8 months
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations.
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 7 Apr 2020.
- Individual participant dataSharing planned: Yes. Public Presentation at ECCMID April 2016
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CF-301 in people with Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia), run by ContraFect at 2 sites 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 14 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Safety and tolerability as measured by AE's (time frame: up to 8 months). 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 7 Apr 2020.