Placebo
DrugTablets for oral administration.
NCT Number: NCT07618247
The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
CMAX, Adelaide, South Australia, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Tablets for oral administration.
Tablets for oral administration.
Time frame: from ICF signing date to Day 10
Time frame: from ICF signing date to Day 23
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Plasma Pharmacokinetics (PK) parameter calculated using a non-compartmental model: tmax (h).
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Plasma PK parameter calculated using a non-compartmental model: Cmax (ng/mL).
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Plasma PK parameter calculated using a non-compartmental model: t1/2 (h)
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Plasma PK parameter calculated using a non-compartmental model: AUC0-24h (h * ng/mL)
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Plasma PK parameter calculated using a non-compartmental model: CL/F (mL/h * kg).
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Time frame: Day 1 to Day 1 or Day 14
Measure the duration of pain tolerance
Contact information is provided by the study sponsor or research team.
Iongen Therapeutics Co., Ltd.
Industry
A Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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