A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

Phase 1

Recruiting

• Conditions: Inflammatory Bowel Disease; Ulcerative colitis; Crohn's Disease; Inflammatory and Immune System - Autoimmune diseases; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12618001210268
• Lead Sponsor: andos Biopharma Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-19
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Healthy male and female volunteers aged 18 to 65 years, inclusive.
2.Body weight 65 - 85 kg.
3.Body Mass Index (weight in kg divided by square of height in meters) 19-31 kg/m2, inclusive.
4.Male volunteers must agree to abstain, between dosing and 30 days post-dosing, from sexual intercourse with pregnant or lactating women and, if sexually active with a female partner, to use a condom in addition to his female partner’s use of another form of contraception (e.g., IUD, diaphragm, oral contraceptive, injectable progesterone contraceptive, subdermal implant contraceptive, or tubal ligation). A male practicing abstinence is also acceptable.
5.Female subjects of child-bearing potential, with a fertile male sexual partner, should be willing to use adequate contraception from Day 1 until 30 days after the follow-up visit. Adequate contraception is defined as an intrauterine device combined with at least one of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
6.Volunteer agrees not to take any concomitant medications, including prescriptions or over-the-counter (OTC) medications during the interval from 3 days prior to dosing until after the last PK blood draw for the study.
7.Volunteer agrees not to consume alcohol during the interval from 3 days prior to dosing until after the last PK blood draw for the study.
8.Volunteer is able to communicate effectively with study personnel.
9.Volunteer is able to understand and comply with protocol and investigative site requirements, instructions, and restrictions.
10.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.

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.
2.An excessive fall in blood pressure on orthostatic testing at screening or Day –1 (i.e., a fall in systolic blood pressure > 25 mmHg or in diastolic blood pressure > 15 mmHg).
3.Any 12-lead ECG finding at screening or on Day –1 that may, in the opinion of the Investigator, compromise interpretation of ECGs for cardiac safety assessment or complicate interpretation of events that may occur post-dose (e.g., QT not accurately measurable, conduction abnormalities)
4.Positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody.
5.Any clinically significant cardiac, pulmonary, renal, metabolic, neurologic, or other medical, behavioural, or genetic condition.
6.Any condition that places the volunteer at significantly increased risk or may risk compromise of study objectives.
7.Use of prescription or non-prescription drugs 3 days or 5 half-lives (whichever is longer) prior to dosing to after last PK draw.
8.Use of herbal supplements within 3 days or 5 half-lives (whichever is longer) prior to the first dose of study drug to after last PK draw.
9.Use of alcohol within 72 hours prior to first dose of study drug.
10.History of drug or alcohol abuse (by DSM-IV definition) within 3 months prior to screening.
11.Positive urine drug screen (including cotinine, cannabis, cocaine, opiates, amphetamines, and other tests as determined by Investigator). Repeating analyses will be allowed if the PI suspects that there might be false positive results.
12.Volunteer has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
13.Volunteer has donated blood or blood products in volumes of 450 mL or more within 30 days prior to study enrollment.
14.Volunteer has been previously exposed to BT-11.
15.Volunteer has participated in a study of any investigational drug, device, biologic, or other agent within 30 days prior to study enrollment.
16.Volunteer has known hypersensitivity to BT-11 or any of its constituents.
17.Volunteer has any disorder (e.g., psychiatric, addictive) that, in Investigator’s judgement, may compromise his/her ability to provide legal written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified