The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Uppsala University Hospital
Uppsala, Sweden
Frequency of adverse events (AEs)
Number and percentage of subjects with adverse events (AEs).
Time frame: 16 days
Clinically significant changes in 12-lead ECGs
Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Time frame: 16 days
Clinically significant changes in vital signs
Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
Time frame: 16 days
Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Time frame: 16 days
Clinically significant changes in physical examinations
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
Time frame: 16 days
GAD-7
Change from baseline of GAD-7
Time frame: 16 days
PHQ-9
Change from baseline of PHQ-9
Time frame: 16 days
C-SSRS
Change from baseline of C-SSRS
Time frame: 16 days
Prolactin
Change from baseline of prolactin levels
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Time frame: 10 days