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First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
Full description
This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
64 healthy male and female subjects are selected according to the inclusion and exclusion criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 [Cohort A], 28 [Cohort B], respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months.
All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A staggered approach is observed within all dose levels. An interval of at least 14 days (last to first administration) is observed between all dose levels. Individual subjects on a same day of dosing are dosed at least 60 minutes apart.
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Inclusion criteria
Subjects meeting all of the following criteria are eligible to participate in this study:
Male or female, aged 18 to 60 years, extremes includes;
In good health condition [medically stable] as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening; Note: a retest can be done in case of an out of range clinical laboratory test value that will determine a subject's eligibility. This retest is preferably to be done at an unscheduled visit. The result of the retest are considered for subject eligibility. If the retest is outside normal reference ranges, the subject are eligible for inclusion only if the investigator judges the abnormalities to be not clinically significant.
Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the investigator; Note: a retest can be done in case of an out of range ECG value that can determine a subject's eligibility.
Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 18.0≤BMI<30.0 kg/m2;
Negative urine test for selected drugs of abuse at screening;
Negative alcohol breath test at screening;
Female subject is postmenopausal or surgically sterile (having had a hysterectomy, bilateral oophorectomy, or tubal ligation);
Female subject has a negative pregnancy test at screening;
Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of an effective method of contraception until 90 days after the last administration of study drug ;
Male subject has to agree not to donate sperm until 90 days after the last administration of study drug;
Willing to adhere to the prohibitions and restrictions specified in this protocol;
Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study;
Subjects were to be EBV-positive as per positive IgG Epstein-Barr nuclear antigen (EBNA) test;
Nonsmoker or light smoker, i.e., smokes maximal 5 cigarettes (or 3 cigars or 3 pipe-full) per day, and ability and willingness to refrain from smoking during confinement and ambulant visits in the clinical research center.
For Part 1, Cohort B only:
The subject did not undergo a KLH challenge.
Exclusion criteria
Subjects meeting one or more of the following criteria are excluded from participation in this study:
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64 participants in 13 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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