ClinicalTrials.gg
Not yet recruitingNCT07924397Updated Nov 9, 2026

A Study to Assess IG001643 in Healthy Participants

A Phase 1 interventional study of IG001643 and Placebo in Pain Management, sponsored by Iongen Therapeutics Co., Ltd.. Not yet recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Iongen Therapeutics Co., Ltd. · Phase 1, Interventional, and Treatment

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001643 in Healthy Participants

02

Conditions studied

  • Pain Management

Keywords

  • Pain Management
03

In context

Lead sponsor

Iongen Therapeutics Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants who have signed the 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 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 , and laboratory tests. And repeat testing is permitted at the discretion of PI or delegate.

Exclusion criteria

Exclusion Criteria:

  1. History or presence of 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 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    IG001643 Single Ascending Doses (SAD)

    Oral administration of IG001643

    Drug: IG001643

  • Placebo comparator
    Placebo Single Ascending Doses (SAD)

    Oral administration of IG001643's matching placebo

    Drug: Placebo

  • Experimental
    IG001643 Multiple Ascending Doses (MAD)

    Oral administration of IG001643

    Drug: IG001643

  • Placebo comparator
    Placebo Multiple Ascending Doses (MAD)

    Oral administration of IG001643's matching placebo

    Drug: Placebo

Interventions

  • DrugIG001643

    IG001643 oral dosage forms

  • DrugPlacebo

    Placebo for oral dosage forms

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) with IG001643

    Number of paticipants with TEAEs, including the lab test variables.

    Time frame: From ICF signing date to Day 15

Secondary outcomes

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

    Plasma Pharmacokinetics (PK) parameter calculated using a non-compartmental model: tmax (h).

    Time frame: SAD: From Day 1 to Day 15 MAD: From Day 1 to Day 28

  2. Observed maximum concentration (Cmax)

    Plasma PK parameter calculated using a non-compartmental model: Cmax (ng/mL).

    Time frame: SAD: From Day 1 to Day 15 MAD: From Day 1 to Day 28

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

    Plasma PK parameter calculated using a non-compartmental model: t1/2 (h)

    Time frame: SAD: From Day 1 to Day 15 MAD: From Day 1 to Day 28

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

    Plasma PK parameter calculated using a non-compartmental model: AUC0-24h (h \* ng/mL)

    Time frame: SAD: From Day 1 to Day 15 MAD: From Day 1 to Day 28

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07924397
Lead sponsor
Iongen Therapeutics Co., Ltd.
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
May 16, 2027 (estimated)
Completion
May 16, 2027 (estimated)
Last update
Nov 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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