About this trial
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.
Eligibility criteria
Qualifiers
Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.
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 .
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SK-09
- Placebo