Normal Healthy Volunteers
Conditions
Brief summary
Study type: Interventional Description of intervention(s) / exposure For single ascending dose, five dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 18.9 - 25.0 mg/kg; 44.3 - 50.0 mg/kg; 68.5 - 75 mg/kg and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1. For multiple ascending dose (once daily for 7 days), three dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 44.3 - 50.0 mg/kg; and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1. White tablets containing 500 mg BT-11 or matching placebo tablets will be dispensed. Single ascending dose duration of administration will be once. For multiple ascending dose it will be up to 7 days. The mode administration will be oral tablet. Compliance and adherence to the intervention will be performed based on the tablet return, tablet not consumed by the subject. The safety monitoring committee will evaluate safety at conclusion of single ascending cohort 2 prior to the commencement of dosing for the multiple ascending dose.
Interventions
DRUGPlacebo
Oral tablet
DRUGBT-11
Oral tablet
Sponsors
NImmune Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Blinded: The people receiving the treatment/s The people administering the treatment/s The people assessing the outcomes
Intervention model description
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Healthy male and female volunteers aged 18 to 65 years, inclusive. 2. Body weight 65 - 85 kg. 3. Volunteer has read, confirmed understanding of, and signed the written informed consent form after the nature of the study and all essential elements of the informed consent document have been fully explained and all of the Volunteer's questions have been answered to his or her satisfaction, prior to initiation of any study procedures. Key
Exclusion criteria
1\. Any clinically significant abnormality identified in the screening history, physical examination (including Vital Signs), laboratory testing, or electrocardiographic testing. Repeat testing of vital signs to confirm the value is allowed. Up to two repeat tests are permitted to confirm eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| PK | 24 hours |
Countries
United States
Outcome results
None listed