A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of SK-09 in Healthy Adult Participants
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Consun Pharmaceutical Group
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Safety Evaluation
Overview
Brief Summary
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.
Detailed Description
Part 1 is a randomized, double-blind, placebo-controlled SAD study to evaluate the safety, tolerability, PK, and PD of single oral doses of SK-09 tablets in healthy adult participants.
Part 2 is a randomized, double-blind, placebo-controlled MAD study designed to evaluate the safety, tolerability, PK, and PD of multiple oral doses of SK-09 tablets in healthy adult participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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 .
Exclusion Criteria
- •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 block, QT prolongation syndrome, or symptoms/family history of QT prolongation syndrome, as assessed by the investigator to be unsuitable for participation.
- •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.
Arms & Interventions
SK-09
Part 1 SAD：Six sequential dose groups will be evaluated, with the planned dose levels as follows: 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg.
Part 2 MAD：Three dose groups (low/medium/high, based on Part 1 SAD results) will be sequentially evaluated.
Intervention: SK-09 (Drug)
Placebo
Part 1 SAD：Six sequential dose groups will be evaluated, with the planned dose levels as follows: 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg.
Part 2 MAD：Three dose groups (low/medium/high, based on Part 1 SAD results) will be sequentially evaluated.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety Evaluation
Time Frame: up to 8 days post-dosing for SAD and up to 20 days post-dosing for MAD
Number of participants with AE, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead ECG readings
Secondary Outcomes
- PK Evaluation（Tmax）(up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD)
- PK Evaluation（Cmax）(up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD)
- PK Evaluation（ AUC0-T）(up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD)
- PK Evaluation ( AUC0-∞）(up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD)
- PD evaluation(up to 12 hour post-dosing on Day 1 for SAD and pending for MAD)