A Phase 1, single-centre, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple dose regimens of GSM-779690T in healthy adults. This first-in-human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSM-779690T.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Opaque capsules for oral consumption
Opaque capsules for oral consumption
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Safety Evaluation
The number of participants with Adverse Events, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal laboratory Test results, abnormal 12-lead Electrocardiogram (ECG) readings.
Time frame: From enrollment up to 7 days post dosing in the SAD and up to 21 days post dosing in the MAD.
Area under the plasma concentration curve versus time curve (AUC) after single GSM-779690T dose.
Evaluate the pharmacokinetics (Area under the plasma concentration curve) of GSM-779690T after a single dose via measuring concentration levels in the blood.
Time frame: At pre-dose, post dose on day 1, Day 2, Day 3, and Day 4.
Area under the plasma concentration versus time curve (AUC) after multiple GSM-779690T doses.
Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of GSM-779690T after multiple doses via measuring concentration levels in the blood.
Time frame: At Pre-Dose, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 16 Post-Dose.
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