The study is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic and food effect of orally administered IPG7236 in healthy adult participants.
The study consists of two parts Part A (Single ascending dose): There are total 8 Single Ascending Dose cohorts. Dose levels are as follows Cohort 1: 25 mg of IPG7236 or placebo as per the randomization code, Cohort 2: 50 mg of IPG7236 or placebo as per the randomization code Cohort 3: 100 mg of IPG7236 or placebo as per the randomization code Cohort 4: 200 mg of IPG7236 or placebo as per the randomization code Cohort 5: 300 mg of IPG7236 or placebo as per the randomization code Cohort 6: 400 mg of IPG7236 or placebo as per the randomization code Cohort 7: 500 mg of IPG7236 or placebo as per the randomization code Cohort 8: 600 mg of IPG7236 or placebo as per the randomization code In Cohort 1 total of 6 subjects enrolled. The 4 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code. In Cohort 2 to Cohort 8, 6 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code. Part B (Multiple ascending dose): There are total 3 Multiple ascending dose cohorts. Dose levels are as follows Cohort 1: 100 mg of IPG7236 or placebo as per the randomization code Cohort 2: 300 mg of IPG7236 or placebo as per the randomization code Cohort 3: 500 mg of IPG7236 or placebo as per the randomization code Total of 8 subjects per cohort, 6 subjects will receive IPG7236 and 2 subjects will receive placebo per the randomization code The Multiple Ascending Dose phase of Cohort 1, Cohort 2 and Cohort 3 will commence based on the safety and tolerability data obtained from Single Ascending Dose phase of Cohort 4, Cohort 6 and Cohort 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Subjects will receive IPG7236 tablets orally once on Day 1 in a fasted state
Subjects will receive IPG7236 tablets orally once daily for 10 days from Day1 to Day 10 in a fasted state
Subjects will receive IPG7236 tablets orally once on Day 1 (Part A) or once daily for 10 days from Day1 to Day 10 (Part B) in a fasted state
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
To assess the safety and tolerability of IPG7236 after ascending single oral doses through adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events v5
Time frame: Up to 36 days
To assess the safety and tolerability of IPG7236 after ascending multiple oral doses through adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events v5
Time frame: Up to 45 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Plasma PK parameters: Cmax (maximum plasma concentration)
Time frame: Up to 36 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Plasma PK parameters: Tmax (time to Cmax)
Time frame: Up to 36 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Plasma PK parameters: Css,max (maximum plasma concentration at steady state)
Time frame: Up to 45 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Plasma PK parameters: CTss,max (time to maximum plasma concentration at steady state)
Time frame: Up to 45 days
To evaluate the effect of food on the PK of IPG7236
Pharmacokinetics parameters using Cmax (maximum plasma concentration)
Time frame: Up to 45 days
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