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Not yet recruiting NCT07618247

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

Phase I Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, IG001119.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug Placebo
    Tablets for oral administration.
  • Drug IG001119
    Tablets for oral administration.

Primary outcome measures

  • The incidence and severity of adverse events（AE） [Time frame: from ICF signing date to Day 10]
  • The incidence and severity of adverse events [Time frame: from ICF signing date to Day 23]
Secondary outcome measures (8)
  • Time to reach the Peak Plasma Concentration (Tmax) [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Observed maximum concentration (Cmax) [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Terminal elimination half-life (t1/2). [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Area under the concentration-time curve (AUC). [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Apparent clearance (CL/F). [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Apparent volume of distribution: Vd/F. [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Elimination rate constant (λz). [Time frame: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
  • Pain tolerance time for the Cold Pain Test [Time frame: Day 1 to Day 1 or Day 14]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • CMAX — Adelaide

Identifiers

NCT: NCT07618247 · IG001119-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗