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Servier Protocol Code:
CL1-95010-001
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT03494712
EudraCT Number:
2017-004180-12
Find a recruiting site
How to participate to the study?
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 1 location
Study description
The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.
Official title: Safety, Tolerability and Pharmacokinetics of S 95010 After Single Escalating Intravenous Doses in Young Healthy Male Subjects. A Randomised, Doubleblind, Placebo-controlled, Monocentre, First-In-Human Study.
Results
English (USA)Conditions
Cardiovascular Diseases
Interventions / Treatments
The treatment(s) given to the participants in the study.
- S 95010
- Placebo
Other study id numbers
Other identification numbers the study may be known by.
- CL1-95010-001
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years to 45 years
(Adult)
Sexes
MaleAccepts Healthy Volunteers
Yes- * Young healthy male subjects aged between 18 and 45 years (both inclusive)
- * Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations
- * Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator
- * History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT > ULN at selection
- * History of renal dysfunction or GFR < 75mL/min/1.73 m2 (MDRD equation) at selection
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Sequential
A sequential study design involves testing treatments one after another in a specific order. Researchers start with one treatment and, based on the results, decide whether to continue with the next treatment. This approach helps to understand the effects of treatments over time.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
S 95010
Increasing single doses of S 95010 to 5 subjects.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
S 95010
Single administration of S 95010 in healthy volunteers
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Placebo Comparator:
Placebo
Increasing single doses of Placebo to 2 subjects.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Other:
Placebo
Single administration of placebo in healthy volunteers
Keywords
Provided by Servier
healthy volunteer
antimiR
single ascending dose
Additional Relevant MeSH Terms Glioma
Cardiovascular Diseases