PainPhase 1NCT07618247
Single Ascending Doses (SAD) and Multiple Ascending Doses(MAD) Study of IG001119 in Healthy Adult Participants
A Phase 1 study testing IG001119 in people with Pain, run by Iongen Therapeutics Co., Ltd. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- IG001119
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Jul 2026to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
CMAX
Adelaide, South Australia, Australia, 5000
Catherine Heyes, +61 420 466 145, catherine.heyes@cmax.com.au
New Zealand1 site, 1 recruiting
- Not yet recruiting
New Zealand Clinical Research
Christchurch, Canterbury, 8011
Julia O'Sullivan, + 64 3 372 9477 ext. 7129, startup@nzcr.co.nz
About this study
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
The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants
- Conditions
- Pain
- Being tested
- Placebo, IG001119
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablets for oral administration.
IG001119Drug
Tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| IG001119 Single Ascending Doses (SAD) | Experimental | Not described Receives: Drug: IG001119 |
| Placebo Single Ascending Doses (SAD) | Placebo comparator | Not described Receives: Drug: Placebo |
| IG001119 Multiple Ascending Doses(MAD) | Experimental | Not described Receives: Drug: IG001119 |
| Placebo Multiple Ascending Doses(MAD) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from ICF signing date to Day 23
Secondary outcomes (8)
Time to reach the Peak Plasma Concentration (Tmax)
Plasma Pharmacokinetics (PK) parameter calculated using a non-compartmental model: tmax (h).
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Observed maximum concentration (Cmax)
Plasma PK parameter calculated using a non-compartmental model: Cmax (ng/mL).
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Terminal elimination half-life (t1/2).
Plasma PK parameter calculated using a non-compartmental model: t1/2 (h)
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Area under the concentration-time curve (AUC).
Plasma PK parameter calculated using a non-compartmental model: AUC0-24h (h * ng/mL)
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Apparent clearance (CL/F).
Plasma PK parameter calculated using a non-compartmental model: CL/F (mL/h * kg).
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Apparent volume of distribution: Vd/F.
- Plasma PK parameter calculated using a non-compartmental model: Vd/F (mL/kg).
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Elimination rate constant (λz).
- Plasma PK parameter calculated using a non-compartmental model: λz (1/h).
Measured: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18
Pain tolerance time for the Cold Pain Test
Measure the duration of pain tolerance
Measured: Day 1 to Day 1 or Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start7 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iongen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618247
- Sponsor's protocol ID
- IG001119-101
- Status last verified
- Sep 2026
- First submitted
- 19 May 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07618247
- Acronym / sponsor ID
- IG001119-101
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Iongen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTablets for oral administration. | Drug | Placebo Multiple Ascending Doses(MAD), Placebo Single Ascending Doses (SAD) |
| IG001119Tablets for oral administration. | Drug | IG001119 Multiple Ascending Doses(MAD), IG001119 Single Ascending Doses (SAD) |
Primary outcome
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IG001119 in people with Pain, run by Iongen Therapeutics Co., Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biao Wang (+86 180 3661 8525, wangbiao@iongenpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events（AE） (time frame: from ICF signing date to Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.