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

31. maj 2026 opdateret af: Iongen Therapeutics Co., Ltd.

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • South Australia
      • Adelaide, South Australia, Australien, Australia, 5000
        • CMAX
        • Kontakt:
          • CMAX

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IG001119 Single Ascending Doses (SAD)
Tablets for oral administration.
Placebo komparator: Placebo Single Ascending Doses (SAD)
Tabletter til oral administration.
Eksperimentel: IG001119 Multiple Ascending Doses(MAD)
Tablets for oral administration.
Placebo komparator: Placebo Multiple Ascending Doses(MAD)
Tabletter til oral administration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence and severity of adverse events
Tidsramme: 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.
from ICF signing date to Day 23
The incidence and severity of adverse events(AE)
Tidsramme: 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.
from ICF signing date to Day 10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Observed maximum concentration (Cmax)
Tidsramme: 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).
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Terminal elimination half-life (t1/2).
Tidsramme: 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)
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Area under the concentration-time curve (AUC).
Tidsramme: 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)
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Apparent clearance (CL/F).
Tidsramme: 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).
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Apparent volume of distribution: Vd/F.
Tidsramme: 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).
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Elimination rate constant (λz).
Tidsramme: 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).
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Pain tolerance time for the Cold Pain Test
Tidsramme: Day 1 to Day 1 or Day 14
Measure the duration of pain tolerance
Day 1 to Day 1 or Day 14
Time to reach the Peak Plasma Concentration (Tmax)
Tidsramme: 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).
SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

4. juni 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. maj 2027

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IG001119-101

Plan for individuelle deltagerdata (IPD)

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