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NCT Number: NCT07618247

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX

Adelaide, South Australia, Australia, 5000, Australia

Location contact

CMAX

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Treatment and study plan

Placebo

Drug

Tablets for oral administration.

IG001119

Drug

Tablets for oral administration.

Primary outcomes

  1. The incidence and severity of adverse events(AE)

    Time frame: 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.
  2. The incidence and severity of adverse events

    Time frame: 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 outcomes

  1. Time to reach the Peak Plasma Concentration (Tmax)

    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).

  2. Observed maximum concentration (Cmax)

    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).

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

    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)

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

    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)

  5. Apparent clearance (CL/F).

    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).

  6. Apparent volume of distribution: Vd/F.

    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: Vd/F (mL/kg).
  7. Elimination rate constant (λz).

    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: λz (1/h).
  8. Pain tolerance time for the Cold Pain Test

    Time frame: Day 1 to Day 1 or Day 14

    Measure the duration of pain tolerance

Sponsors and collaborators

Lead sponsor

Iongen Therapeutics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 3, 2026

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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