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New treatment option for Healthy Participants
Official title First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07412288
What this study is testing
What is KT-579?
KT-579 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a first-in-human study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-579 in healthy male and female adult participants.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Participants with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at...
- Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compliance with requirements and...
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
You likely can't join if
- Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic...
- Participants who have a clinically relevant surgical history (e.g. surgery of the GI tract that could interfere with the PK of the trial medication)...
- Participants with a history of alcohol or substance abuse within the previous 2 years.
- Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the...
- Participants who test positive for alcohol and drugs of abuse at Screening and on admission to the CRU.
- Participants who have acute GI symptoms at the time of Screening or on admission to the CRU (e.g. nausea, vomiting, diarrhea, heartburn).
See the full eligibility criteria
- Participants with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening.
- Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compliance with requirements and restrictions listed in the ICF and in this protocol.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal...
- Participants who have a clinically relevant surgical history (e.g. surgery of the GI tract that could interfere with the PK of the trial medication) Note: prior appendectomy or cholecystectomy is not exclusionary.
- Participants with a history of alcohol or substance abuse within the previous 2 years.
- Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- Participants who test positive for alcohol and drugs of abuse at Screening and on admission to the CRU.
- Participants who have acute GI symptoms at the time of Screening or on admission to the CRU (e.g. nausea, vomiting, diarrhea, heartburn).
- Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening and on admission to the CRU.
- Participants who have previously received KT-579 in another cohort in this study.
- Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives (whichever is longer) of KT-579/placebo administration.
- Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of study drug.
- Male participants (and their partners of childbearing potential) and female participants who do not agree to the contraception requirements as specified in the clinical protocol.
- Female participants who are pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
- Female participants with a positive or undetermined pregnancy test at Screening and on admission to the CRU.
The study team makes the final eligibility decision.
Where it's taking place
- Lincoln, Nebraska, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lincoln, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.