A study to evaluate the safety, tolerability and pharmacokinetics of MAP 315 in healthy adults - Trial ANZCTR12623000291684

Timeline & Enrollment

Primary Outcome

To evaluate the safety and tolerability of MAP 315 when administered to healthy adult participants. Safety and tolerability of MAP 315 will be assessed by the incidence, nature and severity of all adverse events (AEs) and serious adverse events (SAEs) during the study period. AEs will be coded using the most current Medical Dictionary for Regulatory Activities (MedDRA) available at the commencement of the trial. There are no known adverse events for MPA 315 but possible adverse events may include gastrointestinal discomfort. Safety during the study period will also be assessed based on data from: -Clinical laboratory safety analyses (haematology, coagulation, clinical chemistry, and urinalysis) -Vital signs: heart rate, respiratory rate is measured manually by the medical staff using clock; systolic and diastolic blood pressure (SBP and DBP) using sphygmomanometer; and body temperature is measured using tympanic thermometer -heart function measured using 12-lead-electrocardiogram (ECG) -Physical examination includes weight is measured weighing scales, general observations, skin examination, lymph nodes examination, examination of the head, eyes, ears, nose, throat, and extremities, examinations of cardiac system, lungs/respiratory system, abdominal (focusing on liver and spleen).

Summary

This is a first in human study for MAP 315 designed to investigate the safety, tolerability and pharmacokinetics of multiple doses of MAP 315 in healthy adult volunteers. The pharmacodynamic effects of MAP315 will also be explored. The active ingredient of MAP 315 is a live bacterium that is a common member of the gut microbiome of healthy adults. MAP315 is being developed for the treatment of Ulcerative colitis. It is a randomised, double-blind and placebo-controlled study conducted at a single clinical trial centre with a satellite site as an alternate location for screening and outpatient assessments. The study will enroll 2 cohorts of 16 participants each, who will be randomised 3:1 to receive MAP 315 (4 x 10^7 CFU of MAP 315 per capsule) or its matching placebo for 14 consecutive days (2 weeks). The first Cohort will receive one capsule of MAP 315 (4 x 10^7 CFU of MAP 315 per capsule) or matching placebo daily administered orally for 14 consecutive days, (total daily dose of 4 x 10^7 CFU of MAP 315). Cohort 2 will receive four (4) MAP 315 capsules, twice daily for a total of 8 MAP 315 capsules per day for 14 consecutive days, (a total daily dose of 3.2 x 10^8 CFU of MAP 315). The capsules are administered orally with water and regardless of food. Participants in the study will be confined in the clinical research unit (CRU) from Day -1 until Day 3, when they will be discharged after completion of all CRU-based assessments scheduled for that day, in the absence of clinically significant signals, at the discretion of the Principal Investigator. Both dose level cohorts (Cohort 1 and Cohort 2) will include at least 2 sentinel participants: 1 to receive MAP 315 and 1 to receive placebo. If dosing of the sentinel participants proceeds without clinically significant safety signals up to at least 72 hours (h) following the administration of the initial study drug dose, as determined by the Principal Investigator in consultation with the local Medical Monitor and Sponsor if required), the remaining 14 participants in the cohort can be dosed according to the randomisation schedule. The decision to proceed to Cohort 2 of the study will be dependent upon review of data from all participants in Cohort 1 up to at least 6 days after the beginning of dosing (ie, the Day 7 visit) by a safety monitoring committee (SMC). This will include the review of all safety data and available PK data for at least 12 participants in Cohort 1.

ICD-10 Classifications