Single Ascending Doses (SAD) and Multiple Ascending Doses(MAD) Study of IG001119 in Healthy Adult Participants

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

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: IG001119

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, Australia, 5000
      • CMAX
      • Contact: CMAX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IG001119 SAD	Drug: IG001119; Tablets for oral administration.
Placebo Comparator: Placebo SAD	Drug: Placebo; Tablets for oral administration.
Experimental: IG001119 MAD	Drug: IG001119; Tablets for oral administration.
Placebo Comparator: Placebo MAD	Drug: Placebo; Tablets for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of adverse events（AE）	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.	from ICF signing date to Day 10
The incidence and severity of adverse events	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.	from ICF signing date to Day 23

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach the Peak Plasma Concentration (Tmax)	Plasma PK parameter calculated using a non-compartmental model: tmax (h).	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Observed maximum concentration (Cmax)	Plasma PK parameter calculated using a non-compartmental model: Cmax (ng/mL).	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Terminal elimination half-life (t1/2).	Plasma PK parameter calculated using a non-compartmental model: t1/2 (h)	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Area under the concentration-time curve (AUC).	Plasma PK parameter calculated using a non-compartmental model: AUC0-24h (h * ng/mL)	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Apparent clearance (CL/F).	Plasma PK parameter calculated using a non-compartmental model: CL/F (mL/h * kg).	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Apparent volume of distribution: Vd/F.	• Plasma PK parameter calculated using a non-compartmental model: Vd/F (mL/kg).	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Elimination rate constant (λz).	• Plasma PK parameter calculated using a non-compartmental model: λz (1/h).	SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Pain tolerance time for the Cold Pain Test	Measure the duration of pain tolerance	Day 1 to Day 1 or Day 14

Collaborators and Investigators

• Sponsor: Iongen Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 4, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: IG001119-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No