Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers

Inclusion Criteria: IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception IN.2) race: Caucasian IN.3) BW: 50 - 100 kg IN.4) BMI: 20 - 28 kg.m-2 IN.5) age: 21 - 50 years IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit IN.7) willing and able to provide informed consent Exclusion Criteria: General EX.1) Previous participation in the trial EX.2) Participant in any other trial during the last 90 days EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications) EX.5) Presence of acute or chronic infection EX.6) Presence or history of any relevant co-morbidity EX.7) Resting systolic blood pressure \> 140 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes EX.10) Positive serology for HBsAg, anti HBc and anti HCV EX.11) Positive HIV test EX.12) Positive alcohol or urine drug test on recruitment (and upon admission) EX.13) History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products EX.15) Use of prohibited medication EX.16) Suspicion or evidence that the subject is not trustworthy and reliable EX.17) Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard General - all females EX.18) Positive pregnancy test EX.19) Lactating EX.20) Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermicidal gel\] should be used in addition).