Safety and tolerability of BR38 in healthy volunteers: a phase I study

ISRCTN ISRCTN39269910
DOI https://doi.org/10.1186/ISRCTN39269910
Secondary identifying numbers BR38-001
Submission date
13/05/2008
Registration date
15/05/2008
Last edited
12/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniela Bokor
Scientific

Via XXV Aprile 4
San Donato Milanese
20098
Italy

Study information

Study designRandomised, single-blind, placebo-controlled, ascending dose, single-site study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe primary objective is to determine safety and tolerability of ascending single intravenous bolus injection doses of BR38 in healthy male volunteers. The secondary objective is to evaluate the imaging efficacy of BR38 in the myocardium and in the liver.
Ethics approval(s)Ethics approval submitted to Brent Medical Ethics Committee on the 29th April 2008.
Health condition(s) or problem(s) studiedHealthy volunteers
InterventionOne first pilot volunteer will be included at a fixed dose. Thirty six volunteers will then be studied in six-dose groups of six subjects (dose range: 0.005 to 0.32 µl/kg). In each group, four volunteers will be randomly assigned to receive BR38 and two volunteers to receive placebo. Each volunteer will receive a unique intravenous administration. The total duration of volunteer participation in the study from the admission to discharge is anticipated to be five days. The procedure associated with administration will be completed within 20 minutes.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)BR38
Primary outcome measureSafety parameters. All safety parameters will be assessed from the enrolment of the patient and continue for 72 hours post dose at different time points.
Secondary outcome measuresImaging quality. The image quality will be assessed up to one hour following the intravenous injection.
Overall study start date15/06/2008
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit35 Years
SexMale
Target number of participants37 healthy volunteers in total
Key inclusion criteria1. Male volunteer
2. Aged at least 18 years up to 35 years
3. Has a body mass index (BMI) of approximately 18 - 29 kg/m^2 and maximum weight of 100 kg
4. Absence of patent foramen ovale is confirmed by echocardiography
5. Is in good health as determined by medical history, physical examination, neurological examination, electrocardiogram, haematology, plasma chemistry, urinalysis and serology
6. Provides written informed consent and is willing to comply with protocol requirements
Key exclusion criteria1. Has any known allergy to one or more of the ingredients of the investigational product
2. Has received an investigational compound within 30 days before admission into this study
3. Has any medical condition or other circumstances which would significantly decrease the chances obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
4. Had a clinical significant illness within 30 days preceding admission to the study
5. With no visualisation of left ventricle at basal echocardiography and/or without a good B mode ultrasound window for liver at screening
6. Is determined by the investigator that the subject is clinically unsuitable for the study
Date of first enrolment15/06/2008
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Italy
  • United Kingdom

Study participating centre

Via XXV Aprile 4
San Donato Milanese
20098
Italy

Sponsor information

Bracco Imaging S.p.A (Italy)
Industry

Via Folli 50
Milan
20134
Italy

Website http://www.bracco.com/
ROR logo "ROR" https://ror.org/03wjptj96

Funders

Funder type

Industry

Bracco Imaging S.p.A (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2011 Yes No