Pain
Conditions
Brief summary
The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants
Interventions
DRUGPlacebo
Tablets for oral administration.
DRUGIG001119
Tablets for oral administration.
Sponsors
Iongen Therapeutics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2(m) 2) of 18-32 kg/m2(inclusive). 3. Male and female participants who are overtly healthy as judged by the Principal Investigator (PI) or delegate including medical history, physical examination, Vital signs, 12-lead ECG, and laboratory tests. And repeat testing is permitted at the discretion of PI or delegate. Key
Exclusion criteria
1. History or presence of clinically significant acute or chronic diseases of the circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities, which in the opinion of the investigator, make the participant unsuitable for participation. 2. History of childhood asthma (regardless of resolution), depression, migraine, or Gilbert's Syndrome. 3. Hyperkalemia or hypokalemia is deemed clinically significant by the investigator. 4. History of previous episodes of torsades de pointes ventricular tachycardia, or symptomatic ventricular arrhythmia, personal or family history of short QT syndrome or long QT syndrome, or first-degree family history of sudden cardiac death. 5. Major surgery within 6 months prior to screening, or history of surgery that may significantly affect the pharmacokinetic profile or safety evaluation of the investigational drug (e.g., gastrectomy,cholecystectomy, liver or kidney transplantation), or planned surgery during the study. 6. Participants who have received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study. 7. Participants who have used any medication (including prescription drugs, over-the-counter drugs, or herbal products/health supplements) within 5 half-lives or 14 days (whichever is longer) prior to dosing, or who are anticipated to require concomitant medication during the study. 8. Participants with an average daily smoking habit of \>5 cigarettes within 3 months prior to screening, or who are unable to refrain from smoking during the study. 9. Participants deemed by the investigator to be unsuitable for participation for any other reason (e.g., assessed as being excessively sensitive or insensitive to pain), or who are otherwise unlikely to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of adverse events（AE） | from ICF signing date to Day 10 | * Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc. * AEs will be described in terms of result, frequency, intensity, medical decision, relation with study drug, as well as treatment received and subject retirement, duration, and time elapsed. AEs will also be listed and coded using the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary for the term's codification. |
| The incidence and severity of adverse events | from ICF signing date to Day 23 | * Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc. * AEs will be described in terms of result, frequency, intensity, medical decision, relation with study drug, as well as treatment received and subject retirement, duration, and time elapsed. AEs will also be listed and coded using the MedDRA Dictionary for the term's codification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach the Peak Plasma Concentration (Tmax) | 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). |
| Observed maximum concentration (Cmax) | 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). |
| Terminal elimination half-life (t1/2). | 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) |
| Area under the concentration-time curve (AUC). | 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) |
| Apparent clearance (CL/F). | 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). |
| Apparent volume of distribution: Vd/F. | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 | • Plasma PK parameter calculated using a non-compartmental model: Vd/F (mL/kg). |
| Elimination rate constant (λz). | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 | • Plasma PK parameter calculated using a non-compartmental model: λz (1/h). |
| Pain tolerance time for the Cold Pain Test | Day 1 to Day 1 or Day 14 | Measure the duration of pain tolerance |
Countries
Australia, New Zealand
Contacts
CONTACTBiao Wang
Outcome results
None listed