Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
Lead Sponsor:
NImmune Biopharma
Conditions:
Normal Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 m...
Eligibility Criteria
Inclusion
- Key
- Healthy male and female volunteers aged 18 to 65 years, inclusive.
- Body weight 65 - 85 kg.
- 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
- 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.
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03860571
Start Date
July 6 2018
End Date
December 13 2018
Last Update
June 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Site
Blacksburg, Virginia, United States, 24060