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Tests treatment safety and results for FSGS
Official title A Study to Evaluate the Safety, Tolerability and PK of SK-09
ClinicalTrials.gov ID: NCT07267026
What this study is testing
What is SK-09?
SK-09 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fsgs.
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 Phase 1 trial consists of two parts: Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.
- Weight and BMI for female and male participants: Body weight ≥ 50 kg; Body mass index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
- Participants must be in good general health.
- Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
- Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective...
You likely can't join if
- History or current presence of clinically significant Cardiovascular; Respiratory ; Gastrointestinal; Neurological ; Hematologic/immunologic...
- Chronic GI conditions requiring daily medication; or history of bariatric surgery.
- Live/attenuated vaccines within 4 weeks prior to dosing or planned during study.
- Systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure ≥80 mmHg.
- History of myocardial infarction, angina, coronary artery bypass grafting, angioplasty, stenting, congestive heart failure, uncontrolled hypotension...
- Positive results for hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antibodies.
See the full eligibility criteria
- Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.
- Weight and BMI for female and male participants: Body weight ≥ 50 kg; Body mass index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
- Participants must be in good general health.
- Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
- Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .
- History or current presence of clinically significant Cardiovascular; Respiratory ; Gastrointestinal; Neurological ; Hematologic/immunologic disorders.
- Chronic GI conditions requiring daily medication; or history of bariatric surgery.
- Live/attenuated vaccines within 4 weeks prior to dosing or planned during study.
- Systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure ≥80 mmHg.
- History of myocardial infarction, angina, coronary artery bypass grafting, angioplasty, stenting, congestive heart failure, uncontrolled hypotension, unexplained arrhythmia, ventricular tachycardia, atrioventricular...
- Positive results for hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antibodies.
- Major surgery or trauma requiring hospitalization within 6 months.
- Hypersensitivity to any component of SK-09 or its excipients.
- Poor venous access or needle phobia impacting study procedures.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months.
- Current smokers unwilling to abstain during study.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening and confirmed by a single repeat test, if deemed necessary:
- AST or ALT level ≥ 1.5×ULN;
- Total bilirubin level ≥ 1.5×ULN (except Gilbert's with direct bilirubin ≤ ULN)
- Blood loss or donation exceeding 400 mL within 3 months of dosing.
- Other investigational product within 30 days of dosing or 5 half-lives (whichever longer).
- Use of any medications, including over-the-counter drugs, herbal medicine, vitamins, and health supplements, within 2 weeks prior to the first dose or 5 half-lives (whichever longer).
- Positive pregnancy test or breastfeeding.
- Unprotected sexual activity within 2 weeks prior to the first dose.
- Any condition that, in the investigator's opinion, may pose a safety risk to the participant, interfere with the study, or prevent the participant from completing the study or complying with its requirements (due to...
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the...
The study team makes the final eligibility decision.
Where it's taking place
- Herston, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Herston, Queensland, Australia. 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.