Healthy VolunteerPhase 1SC101NCT01872572
Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD
A Phase 1 study testing Subcutaneous RB006 0.5 mg/kg, Subcutaneous RB006 1.0 mg/kg and Subcutaneous RB006 3.0 mg/kg in people with Healthy Volunteer, run by Regado Biosciences, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Subcutaneous RB006 0.5 mg/kg, Subcutaneous RB006 1.0 mg/kg and Subcutaneous RB006 3.0 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2009
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An Institutional Review Board (IRB)-approved informed consent was signed and dated prior to any study-related activities.
- Subject was between the ages of 18 and 45 years, inclusive.
- Subject was a female with a negative urine or serum pregnancy test or postmenopausal for at least 1 year prior to randomization.
- 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.
- Subject had normal (or abnormal and clinically insignificant) laboratory values at Screening.
- Subject was medically normal with no significant abnormal findings at the Screening physical examination.
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- Subject had the ability to understand the requirements of the study and a willingness to comply with all study procedures.
- Subject had not consumed and agreed to abstain from taking any dietary supplements or nonprescription drugs
- Subject had not consumed and agreed to abstain from taking any prescription drugs
- Subject had not consumed alcohol-containing beverages for 3 days prior to CRU admission
- Subject had not consumed grapefruit or grapefruit juice within the 14 days prior to CRU admission
- Subject had not used tobacco or nicotine-containing products within 6 months prior to CRU admission
Who cannot join
- Evidence or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal (GI), cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease.
- Any evidence or history of intracranial bleeding, aneurysm, or thrombotic or hemorrhagic stroke.
- Any known individual or family history of a bleeding diathesis or coagulopathy.
- Active or expected menstruation during the Treatment Phase (females only).
- History of thrombocytopenia associated with abnormal bleeding or risk of a bleeding event, or screening or baseline platelet count <100,000/mm3.
- History of thrombocytosis associated with a thrombotic event or risk for a thrombotic event, or screening or baseline platelet count >600,000/mm3.
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- 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.
- Urinary tract bleeding within 3 months of CRU admission, including microscopic hematuria on screening or baseline urinalysis.
- Unusual or prolonged bleeding (e.g., gum bleeding, nosebleeds, easy bruising), as documented on the Self-Reported Bleeding Questionnaire, at Screening.
- Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months of CRU admission.
- Severe persistent hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg).
- 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.
- Clinically significant liver dysfunction (e.g., as evidenced by elevated liver function tests).
- Clinically significant renal dysfunction (e.g., estimated glomerular filtration rate <60 mL/min or serum creatinine >1.5 mg/dL).
- History of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
- Positive findings on urine drug screen.
- Positive findings for human immunodeficiency virus, hepatitis B, and/or hepatitis C at Screening.
- Pregnant or lactating.
- Acute illness within 1 week of CRU admission.
- A history of alcohol abuse in the past year relative to CRU admission.
- Donated plasma within 7 days of study drug administration.
- Donated 1 or more pints of blood (or equivalent blood loss) within 6 weeks prior to study drug administration.
- Use of an investigational drug within 30 days prior to CRU admission or prior REG1 Anticoagulation System exposure.
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
- Conditions
- Healthy Volunteer
- Being tested
- Subcutaneous RB006 0.5 mg/kg, Subcutaneous RB006 1.0 mg/kg, Subcutaneous RB006 3.0 mg/kg, Subcutaneous RB006 2.0 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous RB006 0.5 mg/kgDrug
Also called SC RB006
Subcutaneous RB006 0.5 mg/kg
Subcutaneous RB006 1.0 mg/kgDrug
Also called SC RB006
Subcutaneous RB006 1.0 mg/kg
Subcutaneous RB006 3.0 mg/kgDrug
Also called SC RB006
Subcutaneous RB006 3.0 mg/kg
Subcutaneous RB006 2.0 mgDrug
Also called SC RB006
- 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.
PlaceboDrug
Also called SC Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Cohort 1: 6 subjects received Subcutaneous RB006 0.5 mg/kg and 2 subjects received SC placebo Receives: Drug: Subcutaneous RB006 0.5 mg/kg; Drug: Placebo |
| Cohort 1-A | Other | Cohort 1-A: 4 subjects received open-label Subcutaneous RB006 0.5 mg/kg Receives: Drug: Subcutaneous RB006 0.5 mg/kg |
| Cohort 2 | Other | Cohort 2: 6 subjects received Subcutaneous RB006 1.0 mg/kg and 2 subjects received SC placebo Receives: Drug: Subcutaneous RB006 1.0 mg/kg; Drug: Placebo |
| Cohort 3 | Other | Cohort 3: 6 subjects received Subcutaneous RB006 3.0 mg/kg and 2 subjects received SC placebo Receives: Drug: Subcutaneous RB006 3.0 mg/kg; Drug: Placebo |
| Cohort 4 | Other | 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 Receives: Drug: Subcutaneous RB006 2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was safety as determined by Treatment Emergent Adverse Events
Measured: 10 days
Secondary outcomes (3)
Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was safety as determined by Serious Adverse Events
Measured: 10 days
Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was pharmacodynamics as determined by change from baseline in aPTT
Measured: 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
Outcome of this study using SC RB006 with and without RB007 in healthy volunteers was pharmacokinetics as determined by Maximum Observed Plasma Concentration (Cmax)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regado Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew M Medlock, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872572
- Sponsor's protocol ID
- REG1-CLINSC101
- Acronym
- SC101
- Status last verified
- Jun 2013
- First submitted
- 2 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vavalle JP, Rusconi CP, Zelenkofske S, Wargin WA, Alexander JH, Becker RC. A phase 1 ascending dose study of a subcutaneously administered factor IXa inhibitor and its active control agent. J Thromb Haemost. 2012 Jul;10(7):1303-11. doi: 10.1111/j.1538-7836.2012.04742.x.
PubMed 22500821Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01872572
- Acronym / sponsor ID
- SC101 / REG1-CLINSC101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Regado Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Jun 2013 (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.
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)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: Subcutaneous RB006 0.5 mg/kg, Drug: PlaceboCohort 1: 6 subjects received Subcutaneous RB006 0.5 mg/kg and 2 subjects received SC placebo |
| Cohort 1-A | Other | Drug: Subcutaneous RB006 0.5 mg/kgCohort 1-A: 4 subjects received open-label Subcutaneous RB006 0.5 mg/kg |
| Cohort 2 | Other | Drug: Subcutaneous RB006 1.0 mg/kg, Drug: PlaceboCohort 2: 6 subjects received Subcutaneous RB006 1.0 mg/kg and 2 subjects received SC placebo |
| Cohort 3 | Other | Drug: Subcutaneous RB006 3.0 mg/kg, Drug: PlaceboCohort 3: 6 subjects received Subcutaneous RB006 3.0 mg/kg and 2 subjects received SC placebo |
| Cohort 4 | Other | Drug: Subcutaneous RB006 2.0 mg8 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- An Institutional Review Board (IRB)-approved informed consent was signed and dated prior to any study-related activities.
- Subject was between the ages of 18 and 45 years, inclusive.
- Subject was a female with a negative urine or serum pregnancy test or postmenopausal for at least 1 year prior to randomization.
- 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.
- Subject had normal (or abnormal and clinically insignificant) laboratory values at Screening.
Key exclusion criteria (23 listed)
- Evidence or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal (GI), cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease.
- Any evidence or history of intracranial bleeding, aneurysm, or thrombotic or hemorrhagic stroke.
- Any known individual or family history of a bleeding diathesis or coagulopathy.
- Active or expected menstruation during the Treatment Phase (females only).
- History of thrombocytopenia associated with abnormal bleeding or risk of a bleeding event, or screening or baseline platelet count <100,000/mm3.
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 |
|---|---|---|
| Subcutaneous RB006 0.5 mg/kgAlso: SC RB006Subcutaneous RB006 0.5 mg/kg | Drug | Cohort 1, Cohort 1-A |
| Subcutaneous RB006 1.0 mg/kgAlso: SC RB006Subcutaneous RB006 1.0 mg/kg | Drug | Cohort 2 |
| Subcutaneous RB006 3.0 mg/kgAlso: SC RB006Subcutaneous RB006 3.0 mg/kg | Drug | Cohort 3 |
| Subcutaneous RB006 2.0 mgAlso: SC RB006* 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. | Drug | Cohort 4 |
| PlaceboAlso: SC PlaceboPlacebo | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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
3 secondary outcomes
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
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
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
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 Jun 2013.
- Results publication: PubMed 22500821Vavalle JP, Rusconi CP, Zelenkofske S, Wargin WA, Alexander JH, Becker RC. A phase 1 ascending dose study of a subcutaneously administered factor IXa inhibitor and its active control agent. J Thromb Haemost. 2012 Jul;10(7):1303-11. doi: 10.1111/j.1538-7836.2012.04742.x.
- Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
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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.
Matthew M Medlock, MD principal investigator
PPD Development, LP
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 Subcutaneous RB006 0.5 mg/kg, Subcutaneous RB006 1.0 mg/kg and Subcutaneous RB006 3.0 mg/kg in people with Healthy Volunteer, run by Regado Biosciences, 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 12 inclusion and 23 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 Jun 2013. 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. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872572, which also lists 2 linked publications.
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 Jun 2013.