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A Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02439359
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
ContraFect

Brief 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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia) Drug: CF-301 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Experimental: CF-301
CF-301
Drug: CF-301
Dose escalation




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Be a healthy female of any race or ethnicity of non-childbearing potential between 18 and 55 years of age, inclusive. OR
  3. Be a healthy non-pregnant, non-lactating female of any race or ethnicity of childbearing potential between 18 and 55 years of age,
  4. Contraception in use for at least 60 days prior to the Screening visit,
  5. Have a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
  6. 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.

Exclusion Criteria:

  1. 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.
  2. 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.

  3. 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.
  4. Has smoked within 28 days prior to receiving study drug or has a positive urine test for cotinine.
  5. A history of serious mental illness.
  6. A history of difficulty donating blood or inadequate venous access.
  7. The donation of blood or plasma within 28 days prior to receiving study drug.
  8. A positive hepatitis screen that tests for both hepatitis B surface antigen (HBsAg) and antibody to hepatitis C virus (HCVAb).
  9. A positive test result for human immunodeficiency virus (HIV) antibody by enzyme immunoassay, which is confirmed by Western blot.
  10. 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).
  11. 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.

  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439359


Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
ContraFect

Responsible Party: ContraFect
ClinicalTrials.gov Identifier: NCT02439359     History of Changes
Other Study ID Numbers: CF 301-101
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public Presentation at ECCMID April 2016

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes