The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Powder for oral solution
Oral solution
SGS Belgium NV - Clinical Pharmacology Unit
Edegem, Belgium
RECRUITINGNumber of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 15 months
Plasma Concentration of Debio 1453P
The PK of Debio 1453P will be evaluated in plasma.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12
Urine Concentration of Debio 1453P
The PK of Debio 1453P will be evaluated in urine.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12
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