HealthyPhase 1CW002NCT01338935
Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of CW002
A Phase 1 study testing CW 002 in people with Healthy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of an investigational neuromuscular blocking agent called CW002 and to document its effects on healthy adult volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from moving. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CW 002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2013
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is male or female in good health (ASA I) between the ages of 18 and 49 years inclusive, with no concurrent disease or illness. Females must be non pregnant, non lactating, and practicing an acceptable method of birth control (e.g., barrier, oral contraceptive, vasectomized partner, abstinence) or be surgically sterile or post menopausal. A pregnancy test will be performed at Screening and on Day 1 to confirm non-pregnant status of female subjects.
- Weighs between 55 and 95 kg, inclusive, and has a body mass index (BMI) between 18 and 30 kg/m2 (BMI calculated as weight in kg/[height in m]2 )
- Agrees to abstain from taking any dietary supplements or non-prescription drugs (except for multivitamins or as authorized by the Investigator and Medical Monitor) for 3 days prior to Baseline through Follow-Up
- Agrees to abstain from taking any prescription drugs (except as authorized by the Investigator and Medical Monitor) during the 14 days prior to Baseline through Follow-Up
- Agrees to abstain from consuming alcohol-containing beverages for 3 days prior to Baseline through Follow-up
- Is in good health (ASA Class I) based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, 12 lead ECG, clinical chemistry, hematology/coagulation, and urinalysis. Seated systolic BP must be > 90 mmHg and ≤ 140 mmHg and seated diastolic BP must be > 50 mmHg and ≤ 90 mmHg at Screening and Baseline
Show all 10Show fewer
- Has no history of cardiovascular, pulmonary, renal, hepatic, central nervous system, or neuromuscular disease, or history of asthma or diabetes (ASA Class I)
- Is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements
- Voluntarily gives written informed consent to participate in the study
- Has available a responsible adult who has agreed to transport the subject home
Who cannot join
- Has any current acute or chronic disease
- Has a history of any clinically important medical disorder including any of the following: cardiovascular, pulmonary, hepatic, renal, CNS or neuromuscular disease, asthma or diabetes
- Has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug
- Has a history of neuromuscular junction disease (e.g., myotonic dystrophy, polio, myasthenia gravis, botulism poisoning)
- Has a history of malignant hyperthermia
- Has had recent (within 2 weeks) use of aminoglycoside antibiotics or corticosteroids
Show all 19Show fewer
- Has a history of sleep apnea
- Has a history of prior anesthetic complications
- Has any history of asthma requiring management for reactive airway disease
- Has a history of an anatomic airway abnormality or indication of an airway abnormality assessed during the Screening airway examination that could interfere with laryngoscopy or tracheal intubation
- Has a history of Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or has a history of viral hepatitis (other than Hepatitis A)
- Has a history of malignancy within the past 5 years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix
- Has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs or any condition that may confound the PK analyses, particularly hepatic or renal disease
- Has received another investigational drug within 30 days prior to the Screening Visit
- Has a history of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit) and/or evidence of any use within 3 days prior to Baseline
- Has a history or current evidence of abuse of licit or illicit drug substances or a positive urine drug screen for drugs of abuse
- Currently uses tobacco-containing products or has a history of tobacco use within 6 months prior to the Screening Visit
- Has donated blood or plasma within 60 days prior to the Screening Visit
- Has an abnormal bleeding tendency
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Phase I, Single-Site, Tri-Institutional, Open-Label, Three-Part, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of CW002 in Healthy Adult Anesthetized Volunteers
The purpose of this study is to test the safety and efficacy of an investigational neuromuscular blocking agent called CW002 and to document its effects on healthy adult volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from moving. CW002 has not yet been approved by the Food and Drug Administration (FDA).
Usually, neuromuscular blocking agents are used together with other drugs that put people completely "asleep". These drugs allow doctors to place a breathing tube in the airway, stop muscles from moving during surgical operations, and allow ventilation (movement of air).
This research is being done because CW002 is expected to act quickly and to provide a muscle block of intermediate (not too long, not too short) duration. The researchers would like to test increasing doses of CW002 that can be given without causing severe side effects. If shown to be both safe and effective, such a compound would be useful in surgical procedures and could improve future anesthetic care.
Read the detailed description
Neuromuscular blocking agents are especially important in intubation (insertion of breathing tube into the windpipe) because a quick and effective muscle block is needed to promptly complete the process and secure the airway. In addition, being able to rapidly reverse a blocking agent is desirable so that the patient can breathe on his/her own as soon as possible.
- Conditions
- Healthy
- Being tested
- CW 002
- Keywords
- CW 002, Phase I trial, safety, efficacy, pharmacokinetics, estimated dose, Neuromuscular Blocking Agents, Treatment Effectiveness, Drug Antagonism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CW 002Drug
For Cohort 1, subjects receive a single bolus of 0.02 mg/kg CW 002 (i.v.) and neuromuscular function will be allowed to recover spontaneously for at least 5 half-lives.
For Cohort 2, an estimated ED50 bolus dose of CW 002 (approximately 0.03 mg/kg) will be given i.v. followed by a second bolus of the same dosage*.
For Cohort 3, an estimated ED 75 bolus dose of CW 002 (approximately 0.04 mg/kg) will be given i.v. followed by a second bolus of the same dosage *.
For Cohort IV, an estimated ED 90 bolus dose of CW 002 (approximately 0.06 mg/kg) will be given i.v. followed by a second bolus of the same dosage*.
*For Cohorts 2-4, a second bolus dose will be administered following a minimum of 5 half-lives of CW002 (based on PK data from Cohort 1).
CW 002Drug
Subjects receive an initial ascending bolus dose of CW 002 injection, and a second bolus followed by a continuous infusion initiated at the point of 25% recovery of twitch response. Infusion rate will be adjusted to maintain 97%- 99% suppression of twitch, but to avoid complete neuromuscular block. For the first 3 subjects of each cohort, CW 002 will be allowed to recover spontaneously. For the second 3 subjects, reversal will be performed at the appearance of 1st twitch using 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate.
Cohort 5- subject receives 2.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 30 min infusion of 2-10 mcg/kg/min of CW 002
Cohort 6 - subject receives 3.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 60 min infusion of 2-10 mcg/kg/min of CW 002
Cohort 7 - subject receives 4.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 90 min infusion of 2-10 mcg/kg/min of CW 002
Bolus doses of ED95 are determined in Part I of the study.
CW 002Drug
In Part III, safety, intubation efficacy, and PK will be evaluated in 2 cohorts (Cohorts 8 and 9) of 6 subjects each, who will undergo endotracheal intubation at 60 or 90 seconds after a bolus dose of CW002 injection at 3 to 4 times the ED95. For the first 3 subjects of each cohort, CW 002 will be allowed to recover spontaneously. For the second 3 subjects, reversal will be performed at the appearance of 1st twitch using 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate.
Cohort 8 - subject receives 3.0x ED95 dose of CW 002, and intubation attempt is made 90 seconds post-bolus.
Cohort 9 - subject receives 4.0x ED95 dose of CW 002, and intubation attempt is made 60 seconds post-bolus.
| Study group | Role | What they receive |
|---|---|---|
| Part I | Experimental | Ascending dose tolerance, PK, and estimation of ED95 for CW 002 Receives: Drug: CW 002 |
| Part II | Experimental | Safety, efficacy and PK of increasing bolus doses and infusions of CW 002, and exploration of Neostigmine reversal Receives: Drug: CW 002 |
| Part III | Experimental | Intubation with CW 002 and Neostigmine reversal Receives: Drug: CW 002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the use of CW002 in healthy human volunteers by monitoring changes in ECG, heart rate (HR), mean arterial pressure, plasma histamine levels, clinical laboratory values, and noting the occurrence of adverse events.
Measured: 4 weeks
Secondary outcomes (1)
To estimate the ED95 (dose required to produce 95% suppression of neuromuscular activity
Neuromuscular activity is measured by the mechanomyographic response of the adductor pollicis (a muscle in the hand that functions to move the thumb muscle) to indirect stimulation.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionNov 2013
Why it stopped: Pharmacokinetic stopping criteria for the study were met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Lien, Weill Medical College of Cornell University
- Investigators
- Cynthia Lien, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338935
- Sponsor's protocol ID
- 1005011060
- Acronym
- CW002
- Status last verified
- Feb 2014
- First submitted
- 18 Apr 2011
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belmont MR, Lien CA, Tjan J, Bradley E, Stein B, Patel SS, Savarese JJ. Clinical pharmacology of GW280430A in humans. Anesthesiology. 2004 Apr;100(4):768-73. doi: 10.1097/00000542-200404000-00004.
PubMed 15087609Donati F. Neuromuscular blocking drugs for the new millennium: current practice, future trends--comparative pharmacology of neuromuscular blocking drugs. Anesth Analg. 2000 May;90(5 Suppl):S2-S6. doi: 10.1097/00000539-200005001-00002. No abstract available.
PubMed 10809511Kopman AF, Klewicka MM, Neuman GG. An alternate method for estimating the dose-response relationships of neuromuscular blocking drugs. Anesth Analg. 2000 May;90(5):1191-7. doi: 10.1097/00000539-200005000-00036.
PubMed 10781478Kopman AF, Klewicka MM, Neuman GG. Reexamined: the recommended endotracheal intubating dose for nondepolarizing neuromuscular blockers of rapid onset. Anesth Analg. 2001 Oct;93(4):954-9. doi: 10.1097/00000539-200110000-00030.
PubMed 11574363Savarese JJ, McGilvra JD, Sunaga H, Belmont MR, Van Ornum SG, Savard PM, Heerdt PM. Rapid chemical antagonism of neuromuscular blockade by L-cysteine adduction to and inactivation of the olefinic (double-bonded) isoquinolinium diester compounds gantacurium (AV430A), CW 002, and CW 011. Anesthesiology. 2010 Jul;113(1):58-73. doi: 10.1097/ALN.0b013e3181dc1b5b.
PubMed 20526187Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x.
PubMed 8904261
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Site, Tri-Institutional, Open-Label, Three-Part, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of CW002 in Healthy Adult Anesthetized Volunteers
- ClinicalTrials.gov ID
- NCT01338935
- Acronym / sponsor ID
- CW002 / 1005011060
- Conditions
- Healthy
- Keywords
- CW 002, Phase I trial, safety, efficacy, pharmacokinetics, estimated dose, Neuromuscular Blocking Agents, Treatment Effectiveness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmacokinetic stopping criteria for the study were met.
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Apr 2011 (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.
The purpose of this study is to test the safety and efficacy of an investigational neuromuscular blocking agent called CW002 and to document its effects on healthy adult volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from moving. CW002 has not yet been approved by the Food and Drug Administration (FDA).
Usually, neuromuscular blocking agents are used together with other drugs that put people completely "asleep". These drugs allow doctors to place a breathing tube in the airway, stop muscles from moving during surgical operations, and allow ventilation (movement of air).
This research is being done because CW002 is expected to act quickly and to provide a muscle block of intermediate (not too long, not too short) duration. The researchers would like to test increasing doses of CW002 that can be given without causing severe side effects. If shown to be both safe and effective, such a compound would be useful in surgical procedures and could improve future anesthetic care.
Detailed description
Neuromuscular blocking agents are especially important in intubation (insertion of breathing tube into the windpipe) because a quick and effective muscle block is needed to promptly complete the process and secure the airway. In addition, being able to rapidly reverse a blocking agent is desirable so that the patient can breathe on his/her own as soon as possible.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I | Experimental | Drug: CW 002Ascending dose tolerance, PK, and estimation of ED95 for CW 002 |
| Part II | Experimental | Drug: CW 002Safety, efficacy and PK of increasing bolus doses and infusions of CW 002, and exploration of Neostigmine reversal |
| Part III | Experimental | Drug: CW 002Intubation with CW 002 and Neostigmine reversal |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Is male or female in good health (ASA I) between the ages of 18 and 49 years inclusive, with no concurrent disease or illness. Females must be non pregnant, non lactating, and practicing an acceptable method of birth control (e.g., barrier, oral contraceptive, vasectomized partner, abstinence) or be surgically sterile or post menopausal. A pregnancy test will be performed at Screening and on Day 1 to confirm non-pregnant status of female subjects.
- Weighs between 55 and 95 kg, inclusive, and has a body mass index (BMI) between 18 and 30 kg/m2 (BMI calculated as weight in kg/[height in m]2 )
- Agrees to abstain from taking any dietary supplements or non-prescription drugs (except for multivitamins or as authorized by the Investigator and Medical Monitor) for 3 days prior to Baseline through Follow-Up
- Agrees to abstain from taking any prescription drugs (except as authorized by the Investigator and Medical Monitor) during the 14 days prior to Baseline through Follow-Up
- Agrees to abstain from consuming alcohol-containing beverages for 3 days prior to Baseline through Follow-up
Key exclusion criteria (19 listed)
- Has any current acute or chronic disease
- Has a history of any clinically important medical disorder including any of the following: cardiovascular, pulmonary, hepatic, renal, CNS or neuromuscular disease, asthma or diabetes
- Has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug
- Has a history of neuromuscular junction disease (e.g., myotonic dystrophy, polio, myasthenia gravis, botulism poisoning)
- Has a history of malignant hyperthermia
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 |
|---|---|---|
| CW 002For Cohort 1, subjects receive a single bolus of 0.02 mg/kg CW 002 (i.v.) and neuromuscular function will be allowed to recover spontaneously for at least 5 half-lives. For Cohort 2, an estimated ED50 bolus dose of CW 002 (approximately 0.03 mg/kg) will be given i.v. followed by a second bolus of the same dosage*. For Cohort 3, an estimated ED 75 bolus dose of CW 002 (approximately 0.04 mg/kg) will be given i.v. followed by a second bolus of the same dosage *. For Cohort IV, an estimated ED 90 bolus dose of CW 002 (approximately 0.06 mg/kg) will be given i.v. followed by a second bolus of the same dosage*. *For Cohorts 2-4, a second bolus dose will be administered following a minimum of 5 half-lives of CW002 (based on PK data from Cohort 1). | Drug | Part I |
| CW 002Subjects receive an initial ascending bolus dose of CW 002 injection, and a second bolus followed by a continuous infusion initiated at the point of 25% recovery of twitch response. Infusion rate will be adjusted to maintain 97%- 99% suppression of twitch, but to avoid complete neuromuscular block. For the first 3 subjects of each cohort, CW 002 will be allowed to recover spontaneously. For the second 3 subjects, reversal will be performed at the appearance of 1st twitch using 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate. Cohort 5- subject receives 2.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 30 min infusion of 2-10 mcg/kg/min of CW 002 Cohort 6 - subject receives 3.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 60 min infusion of 2-10 mcg/kg/min of CW 002 Cohort 7 - subject receives 4.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 90 min infusion of 2-10 mcg/kg/min of CW 002 Bolus doses of ED95 are determined in Part I of the study. | Drug | Part II |
| CW 002In Part III, safety, intubation efficacy, and PK will be evaluated in 2 cohorts (Cohorts 8 and 9) of 6 subjects each, who will undergo endotracheal intubation at 60 or 90 seconds after a bolus dose of CW002 injection at 3 to 4 times the ED95. For the first 3 subjects of each cohort, CW 002 will be allowed to recover spontaneously. For the second 3 subjects, reversal will be performed at the appearance of 1st twitch using 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate. Cohort 8 - subject receives 3.0x ED95 dose of CW 002, and intubation attempt is made 90 seconds post-bolus. Cohort 9 - subject receives 4.0x ED95 dose of CW 002, and intubation attempt is made 60 seconds post-bolus. | Drug | Part III |
Primary outcome
To evaluate the safety of the use of CW002 in healthy human volunteers by monitoring changes in ECG, heart rate (HR), mean arterial pressure, plasma histamine levels, clinical laboratory values, and noting the occurrence of adverse events.
Time frame: 4 weeks
1 secondary outcome
To estimate the ED95 (dose required to produce 95% suppression of neuromuscular activity
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Pharmacokinetic stopping criteria for the study were met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Background: PubMed 15087609Belmont MR, Lien CA, Tjan J, Bradley E, Stein B, Patel SS, Savarese JJ. Clinical pharmacology of GW280430A in humans. Anesthesiology. 2004 Apr;100(4):768-73. doi: 10.1097/00000542-200404000-00004.
- Background: PubMed 10809511Donati F. Neuromuscular blocking drugs for the new millennium: current practice, future trends--comparative pharmacology of neuromuscular blocking drugs. Anesth Analg. 2000 May;90(5 Suppl):S2-S6. doi: 10.1097/00000539-200005001-00002. No abstract available.
- Background: PubMed 10781478Kopman AF, Klewicka MM, Neuman GG. An alternate method for estimating the dose-response relationships of neuromuscular blocking drugs. Anesth Analg. 2000 May;90(5):1191-7. doi: 10.1097/00000539-200005000-00036.
- Background: PubMed 11574363Kopman AF, Klewicka MM, Neuman GG. Reexamined: the recommended endotracheal intubating dose for nondepolarizing neuromuscular blockers of rapid onset. Anesth Analg. 2001 Oct;93(4):954-9. doi: 10.1097/00000539-200110000-00030.
- Background: PubMed 20526187Savarese JJ, McGilvra JD, Sunaga H, Belmont MR, Van Ornum SG, Savard PM, Heerdt PM. Rapid chemical antagonism of neuromuscular blockade by L-cysteine adduction to and inactivation of the olefinic (double-bonded) isoquinolinium diester compounds gantacurium (AV430A), CW 002, and CW 011. Anesthesiology. 2010 Jul;113(1):58-73. doi: 10.1097/ALN.0b013e3181dc1b5b.
- Background: PubMed 8904261Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x.
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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.
Cynthia Lien, MD principal investigator
Weill Medical College of Cornell University
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 CW 002 in people with Healthy, run by Weill Medical College of Cornell University 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 10 inclusion and 19 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: stopped early, as of the sponsor's last update on 4 Feb 2014. 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 was stopped early (reason given: Pharmacokinetic stopping criteria for the study were met.). Results are not available in the source record.
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?
To evaluate the safety of the use of CW002 in healthy human volunteers by monitoring changes in ECG, heart rate (HR), mean arterial pressure, plasma histamine levels, clinical laboratory values, and noting the occurrence of adverse events. (time frame: 4 weeks). 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 NCT01338935, which also lists 6 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 4 Feb 2014.