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 range

19 Years – 50 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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.

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 range

19 Years – 50 Years

Sex

ALL

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.

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.