CompletedPhase 1

Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects

United States28 participantsStarted 2021-02-03

Plain-language summary

A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects

Who can participate

Age range19 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
✓. Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
✓. Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per Division of Microbiology and Infectious Diseases Toxicity Tables), as deemed by the Investigator.
✓. Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
✓. If assigned to receive study drug under fed conditions, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.

Exclusion criteria

✕. History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
✕. Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
✕. Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
✕. QTcF interval \>450 msec for males or \>470 msec for females at screening, Day -1, or Day 1 (predose), or history of prolonged QT syndrome. For the triplicate 12-lead ECGs taken at screening and on Day -1, the average QTcF interval of the three 12-lead ECG recordings were used to determine qualification.

What they're measuring

Safety assessment Vital Signs - Blood pressure

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Pulse rate

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Respiration rate

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Temperature

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Pulse oximetry

Timeframe: through study completion, 12 weeks.

Safety assessment - Cardiac monitoring

Timeframe: through study completion, 12 weeks.

Safety assessment - Adverse Events (AEs)

Timeframe: through study completion, 12 weeks.

Safety assessment Clinical Laboratory Tests - Hematology

Timeframe: through study completion, 12 weeks.

Trial details

NCT IDNCT04865536

SponsorGlobal Alliance for TB Drug Development

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-17

View on ClinicalTrials.gov More Tuberculosis trials

Who can participate

Age range19 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
✓. Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
✓. Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per Division of Microbiology and Infectious Diseases Toxicity Tables), as deemed by the Investigator.
✓. Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
✓. If assigned to receive study drug under fed conditions, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.

Exclusion criteria

✕. History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
✕. Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
✕. Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
✕. QTcF interval \>450 msec for males or \>470 msec for females at screening, Day -1, or Day 1 (predose), or history of prolonged QT syndrome. For the triplicate 12-lead ECGs taken at screening and on Day -1, the average QTcF interval of the three 12-lead ECG recordings were used to determine qualification.

What they're measuring

Safety assessment Vital Signs - Blood pressure

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Pulse rate

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Respiration rate

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Temperature

Timeframe: through study completion, 12 weeks.

Safety assessment Vital Signs - Pulse oximetry

Timeframe: through study completion, 12 weeks.

Safety assessment - Cardiac monitoring

Timeframe: through study completion, 12 weeks.

Safety assessment - Adverse Events (AEs)

Timeframe: through study completion, 12 weeks.

Safety assessment Clinical Laboratory Tests - Hematology

Timeframe: through study completion, 12 weeks.