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

NCT07618247 | Not Yet Recruiting Phase 1

• 1 other identifier: IG001119-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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 Medical Dictionary for Regulatory Activities (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 Outcomes (8)

• Time to reach the Peak Plasma Concentration (Tmax)

  SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18

• Observed maximum concentration (Cmax)

  SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18

• Terminal elimination half-life (t1/2).

  SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18

• Area under the concentration-time curve (AUC).

  SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18

• Apparent clearance (CL/F).

  SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18

Study Arms (4)

IG001119 Single Ascending Doses (SAD)

EXPERIMENTAL

Drug: IG001119

Placebo Single Ascending Doses (SAD)

PLACEBO COMPARATOR

Drug: Placebo

IG001119 Multiple Ascending Doses(MAD)

EXPERIMENTAL

Drug: IG001119

Placebo Multiple Ascending Doses(MAD)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Tablets for oral administration.

Placebo Multiple Ascending Doses(MAD); Placebo Single Ascending Doses (SAD)

IG001119 DRUG

Tablets for oral administration.

IG001119 Multiple Ascending Doses(MAD); IG001119 Single Ascending Doses (SAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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.

You may not qualify if:

• 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.
• History of childhood asthma (regardless of resolution), depression, migraine, or Gilbert's Syndrome.
• Hyperkalemia or hypokalemia is deemed clinically significant by the investigator.
• 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.
• 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.
• Participants who have received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Iongen Therapeutics Co., Ltd.: lead

Study Sites (1)

CMAX

Adelaide, South Australia, Australia, 5000, Australia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 1, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)