HealthyPhase 1NCT01334697
Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Cardiotrophin-1 in Healthy Volunteers
A Phase 1 study testing recombinant human cardiotrophin-1 in people with Healthy, run by Digna Biotech S.L. at 2 sites in Spain.
Trial summary
The general aim of the study is to determinate safety, tolerability and early pharmacokinetics of cardiotrophin.1 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- recombinant human cardiotrophin-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2012to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female, between the ages of 18 and 55.
- Healthy condition (no suffering from known acute or chronic disease)
- No clinically important abnormal physical or laboratory findings at the screening examination.
- Normal or clinically acceptable ECG.
- Normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (40-100 bpm).
- Body Mass Index of 19.0-29.0 (kg/m2).
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- Ability to communicate well with the investigator and to comply with the requirements of the entire study.
- Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
- For female subjects with childbearing potential: use of a known highly effective method of birth control, defined as those which results in a low failure rate: i.e. less 1% per year, (contraceptive pills, intrauterine contraceptive device, implants, vasectomized partner or sexual abstinence), for at least three consecutive months prior to the study, during the study and one month after the end of the study.
- For male subjects with partners of child bearing potential: use of appropriate contraceptive methods (vasectomy, condoms or sexual abstinence), for at least the study period and one month after the end of the study.
Who cannot join
- Administration of any investigational drug in the period within three months prior to informed consent.
- Use of any prescription medication during the period 0 to 30 days or over-the-counter medication during the 0 to 5 days before entry to the study.
- Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
- Serious adverse reaction or hypersensitivity to any drug.
- Inability to communicate or co-operate with the investigator because of a language problem, poor mental development or impaired cerebral function.
- History of drug dependence (except tobacco) or psychiatric illness within the past 2 years.
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- Consumption of alcohol within 24 hours prior to dose administration.
- Presence of pain incurred by unknown causes.
- Pregnancy or nursing.
- Positive urine drug screen for drugs with a high potential for abuse and low persistence in the urine.
- Inability to refrain from smoking during study days.
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hosp. Universitario Puerta de Hierro de Majadahonda
Madrid
Clínica Universidad de Navarra
Pamplona
About this study
Official title: Phase I, Randomized, Multicenter, Double-blind, Single Dose, Dose-Escalation, Placebo-Controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous Administration of Cardiotrophin-1 (CT-1)in Healthy Volunteers
The general aim of the study is to determinate safety, tolerability and early pharmacokinetics of cardiotrophin.1 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- recombinant human cardiotrophin-1, Placebo
- Keywords
- Cardiotrophin-1, CT-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human cardiotrophin-1Drug
Single dose intravenous administration
PlaceboOther
Single dose intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Cardiotrophin-1 | Experimental | Not described Receives: Drug: recombinant human cardiotrophin-1 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Evaluate the tolerability and safety of single dose intravenous administration
Measured: single dose administration (baseline) and 1 post-treatment follow up week
Secondary outcomes (1)
Pharmacokinetic and Pharmacodynamic parameters
Obtain pharmacokinetic parameters before and after CT-1 single dose administration.
Analyze surrogated biological markers associated with CT-1 administration
Measured: single adminsitration (baseline) and 1 week of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startNov 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digna Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belén Sádaba, MD, Principal investigator, Clínica Universidad de Pamplona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334697
- Sponsor's protocol ID
- CT1-HEPT-01, 2010-022929-15
- Status last verified
- Jul 2013
- First submitted
- 5 Apr 2011
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Multicenter, Double-blind, Single Dose, Dose-Escalation, Placebo-Controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous Administration of Cardiotrophin-1 (CT-1)in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01334697
- Acronym / sponsor ID
- CT1-HEPT-01, 2010-022929-15
- Conditions
- Healthy
- Keywords
- Cardiotrophin-1, CT-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Digna Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 13 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 general aim of the study is to determinate safety, tolerability and early pharmacokinetics of cardiotrophin.1 in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiotrophin-1 | Experimental | Drug: recombinant human cardiotrophin-1 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or Female, between the ages of 18 and 55.
- Healthy condition (no suffering from known acute or chronic disease)
- No clinically important abnormal physical or laboratory findings at the screening examination.
- Normal or clinically acceptable ECG.
- Normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (40-100 bpm).
Key exclusion criteria (12 listed)
- Administration of any investigational drug in the period within three months prior to informed consent.
- Use of any prescription medication during the period 0 to 30 days or over-the-counter medication during the 0 to 5 days before entry to the study.
- Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
- Serious adverse reaction or hypersensitivity to any drug.
- Inability to communicate or co-operate with the investigator because of a language problem, poor mental development or impaired cerebral function.
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 |
|---|---|---|
| recombinant human cardiotrophin-1Single dose intravenous administration | Drug | Cardiotrophin-1 |
| PlaceboSingle dose intravenous administration | Other | Placebo |
Primary outcome
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: single dose administration (baseline) and 1 post-treatment follow up week
Evaluate the tolerability and safety of single dose intravenous administration
1 secondary outcome
Pharmacokinetic and Pharmacodynamic parameters
Time frame: single adminsitration (baseline) and 1 week of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Treatment of murine fulminant hepatitis with genetically engineered endothelial progenitor cells.Link provided by the sponsor.
- \[Obesity, inflammation and insulin resistance: role of gp 130 receptor ligands\].Link provided by the sponsor.
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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.
Belén Sádaba, MD principal investigator
Clínica Universidad de Pamplona
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 recombinant human cardiotrophin-1 in people with Healthy, run by Digna Biotech S.L. at 2 sites in Spain.
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 12 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: status not confirmed, as of the sponsor's last update on 30 Jul 2013. 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 Spain. 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?
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?
Number of participants with Adverse Events as a Measure of Safety and Tolerability (time frame: single dose administration (baseline) and 1 post-treatment follow up week). 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 30 Jul 2013.