This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered 83-0060 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Scientia Clinical Research
Sydney, Greater Sydney Area, Australia
Incidence of AEs
Incidence of Adverse Events observed during the study
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of drug-related AEs
Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of SAEs
Incidence of Serious Adverse Events observed during the study
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of lab deviations
Incidence of clinically relevant deviations in the clinical laboratory parameters
Time frame: 8 days in SAD part, 17 days for MAD part
Plasma concentration
Plasma concentration, ng/mL
Time frame: 8 days in SAD part, 17 days for MAD part
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