Main objective• To determine the safety and tolerability of multiple dosing of SPC3649Secondary objectives• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649 administered by i.v. and s.c. route in healthy volunteers• To evaluate the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the safety and tolerability of multiple dosing of SPC3649
Secondary outcome
• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649
administered by i.v. and s.c. route in healthy volunteers
• To evaluate the bioavailability of s.c. administration of SPC3649
• To investigate the effect of multiple dosing of SPC3649 on lipids as
surrogate markers of miR-122 inhibition
Background summary
Possible new treatment of Hepatitis C with SPC3649
Study objective
Main objective
• To determine the safety and tolerability of multiple dosing of SPC3649
Secondary objectives
• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649
administered by i.v. and s.c. route in healthy volunteers
• To evaluate the bioavailability of s.c. administration of SPC3649
• To investigate the effect of multiple dosing of SPC3649 on lipids as
surrogate markers
Study design
This is a placebo-controlled, double-blind, randomised, multiple
dose-escalating safety study in healthy volunteers, each subject will receive 5
doses either as a 2 hour intravenous infusion (i.v.) or as a subcutaneous
(s.c.) injection with either SPC3649 or placebo once weekly.
Intervention
Treatment with SPC3649
Study burden and risks
The total study duration is 6 month and during that time the subjects will be
admitted to the clinic for 2 x 24 hours and they will visit the clinic on
regular ambulatory visits. The medication will be administered as i.v. or s.c.
injections. During each visit blood samples will be drawn. Blood sampling can
give light pain and very seldom infection. In the first study 48 subjects were
treated with a single dose of SPC3649 as i.v. infusion without any injection
site reaction. However, s.c. injection could cause mild and temporal injection
site reaction as known from other antisense drugs. . In the First-in-Man study
overall SPC3649 appeared to be safe and well tolerated. The adverse events
observed were mild or moderate and resolved spontaneously. In this study the
lipids were reduced, which can also be expected in this study. It is not
expected that the study subjects will have any lasting benefits from
participation in the study.
Kogle Allé 6
DK-2970
Denmark
Kogle Allé 6
DK-2970
Denmark
Listed location countries
Age
Inclusion criteria
• Healthy volunteers
• Males, postmenopausal (>1 year since last menstruation) or hysterectomised female
• Age >=18 to 60 years
• BMI: 18 - 30 kg/m2
• No clinically significant disease/disorder
• No clinically significant abnormalities at Screening laboratory tests
• Male subjects must agree to use birth control (condoms) during the whole study period
• Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out
Exclusion criteria
• Alcohol intake >=21 units weekly for men, and >=14 units for women
• smoke >10 cigarettes per day
• Received experimental drug within 60 days of study entry
• Planned participation in any experimental study during the study period
• HIV-Ab, HBsAg and/or HCV Ab positive
• Abnormal blood pressure (systolic >140 mmHg and/or diastolic blood pressure >90 mmHg)
• Current use of any drug or narcotics
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012153-38-NL |
| CCMO | NL28003.000.09 |