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Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD (SC101)

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ClinicalTrials.gov Identifier: NCT01872572
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Regado Biosciences, Inc.

Brief Summary:

This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of the safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an SC injection, with and without IV RB007 (an active control agent for RB006), in healthy young volunteers. The study originally planned to enroll 4 cohorts of 8 subjects each (N=32); however, upon review cohort (Cohort 1-A) was necessary in order to fully define the PK profile of SC RB006. Therefore, 36 subjects were enrolled in this study.

Each cohort was balanced by sex with no more than 2/3 of one sex enrolled in any particular cohort (i.e., 5 of 8 subjects in each cohort). No subject participated in >1 dose group, and progression to the next higher dose only occurred if the prior dose level was well tolerated, as assessed by a Safety Review Committee (SRC)


Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Subcutaneous RB006 0.5 mg/kg Drug: Subcutaneous RB006 1.0 mg/kg Drug: Subcutaneous RB006 3.0 mg/kg Drug: Subcutaneous RB006 2.0 mg Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RB006 Administered Subcutaneously, With and Without IV RB007, in Healthy Young Volunteers
Study Start Date : August 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Cohort 1
Cohort 1: 6 subjects received Subcutaneous RB006 0.5 mg/kg and 2 subjects received SC placebo
Drug: Subcutaneous RB006 0.5 mg/kg
Subcutaneous RB006 0.5 mg/kg
Other Name: SC RB006

Drug: Placebo
Placebo
Other Name: SC Placebo

Cohort 1-A
Cohort 1-A: 4 subjects received open-label Subcutaneous RB006 0.5 mg/kg
Drug: Subcutaneous RB006 0.5 mg/kg
Subcutaneous RB006 0.5 mg/kg
Other Name: SC RB006

Cohort 2
Cohort 2: 6 subjects received Subcutaneous RB006 1.0 mg/kg and 2 subjects received SC placebo
Drug: Subcutaneous RB006 1.0 mg/kg
Subcutaneous RB006 1.0 mg/kg
Other Name: SC RB006

Drug: Placebo
Placebo
Other Name: SC Placebo

Cohort 3
Cohort 3: 6 subjects received Subcutaneous RB006 3.0 mg/kg and 2 subjects received SC placebo
Drug: Subcutaneous RB006 3.0 mg/kg
Subcutaneous RB006 3.0 mg/kg
Other Name: SC RB006

Drug: Placebo
Placebo
Other Name: SC Placebo

Cohort 4

8 subjects received subcutaneous RB006 2.0 mg/kg as well as the following:

  • 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 72 hours post-RB006 administration
  • 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 24, 72, and 120 hours post-RB006 administration
Drug: Subcutaneous RB006 2.0 mg
  • Arm 1: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 72 hours post-RB006 administration
  • Arm 2: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 24, 72, and 120 hours post-RB006 administration.
Other Name: SC RB006




Primary Outcome Measures :
  1. Primary Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was safety as determined by Treatment Emergent Adverse Events [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was safety as determined by Serious Adverse Events [ Time Frame: 10 days ]
  2. Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was pharmacodynamics as determined by change from baseline in aPTT [ Time Frame: Pre-dose, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216 (and if applicable, 264) hours post RB006 dose ]
  3. Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was pharmacokinetics as determined by Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 48, 60, 72, 84, 96, 120, 144, 168, and 216 (and if applicable, 264) hours post-RB006 dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. An Institutional Review Board (IRB)-approved informed consent was signed and dated prior to any study-related activities.
  2. Subject was between the ages of 18 and 45 years, inclusive.
  3. Subject was a female with a negative urine or serum pregnancy test or postmenopausal for at least 1 year prior to randomization.
  4. Subject had a body mass index (BMI) between 18 kg/m2 and 32 kg/m2 (weight/[height]2) and was ≥50 kg and ≤120 kg total body weight.
  5. Subject had normal (or abnormal and clinically insignificant) laboratory values at Screening.
  6. Subject was medically normal with no significant abnormal findings at the Screening physical examination.
  7. Subject had the ability to understand the requirements of the study and a willingness to comply with all study procedures.
  8. Subject had not consumed and agreed to abstain from taking any dietary supplements or nonprescription drugs
  9. Subject had not consumed and agreed to abstain from taking any prescription drugs
  10. Subject had not consumed alcohol-containing beverages for 3 days prior to CRU admission
  11. Subject had not consumed grapefruit or grapefruit juice within the 14 days prior to CRU admission
  12. Subject had not used tobacco or nicotine-containing products within 6 months prior to CRU admission

Exclusion Criteria:

  1. Evidence or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal (GI), cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease.
  2. Any evidence or history of intracranial bleeding, aneurysm, or thrombotic or hemorrhagic stroke.
  3. Any known individual or family history of a bleeding diathesis or coagulopathy.
  4. Active or expected menstruation during the Treatment Phase (females only).
  5. History of thrombocytopenia associated with abnormal bleeding or risk of a bleeding event, or screening or baseline platelet count <100,000/mm3.
  6. History of thrombocytosis associated with a thrombotic event or risk for a thrombotic event, or screening or baseline platelet count >600,000/mm3.
  7. Endoscopically confirmed peptic ulcer disease within 3 years of CRU admission or GI bleeding within 3 months of CRU admission, including a positive stool for occult blood at Screening or Baseline.
  8. Urinary tract bleeding within 3 months of CRU admission, including microscopic hematuria on screening or baseline urinalysis.
  9. Unusual or prolonged bleeding (e.g., gum bleeding, nosebleeds, easy bruising), as documented on the Self-Reported Bleeding Questionnaire, at Screening.
  10. Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months of CRU admission.
  11. Severe persistent hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg).
  12. Baseline hemoglobin <12.0 g/dL for males or <11.0 g/dL for females; prothrombin time (PT) greater than the ULN; or aPTT greater than the ULN.
  13. Clinically significant liver dysfunction (e.g., as evidenced by elevated liver function tests).
  14. Clinically significant renal dysfunction (e.g., estimated glomerular filtration rate <60 mL/min or serum creatinine >1.5 mg/dL).
  15. History of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
  16. Positive findings on urine drug screen.
  17. Positive findings for human immunodeficiency virus, hepatitis B, and/or hepatitis C at Screening.
  18. Pregnant or lactating.
  19. Acute illness within 1 week of CRU admission.
  20. A history of alcohol abuse in the past year relative to CRU admission.
  21. Donated plasma within 7 days of study drug administration.
  22. Donated 1 or more pints of blood (or equivalent blood loss) within 6 weeks prior to study drug administration.
  23. Use of an investigational drug within 30 days prior to CRU admission or prior REG1 Anticoagulation System exposure.

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): NCT01872572


Locations
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United States, Texas
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Regado Biosciences, Inc.
Investigators
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Principal Investigator: Matthew M Medlock, MD PPD

Publications of Results:
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Responsible Party: Regado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01872572     History of Changes
Other Study ID Numbers: REG1-CLINSC101
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013