Healthy ParticipantsPhase 1NCT05604287
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
A Phase 1 study testing ID119031166M in people with Healthy Participants, run by IlDong Pharmaceutical Co Ltd at 1 site in United States.
Trial summary
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- ID119031166M
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 12 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be Caucasian (White American of European or Latin American descent).
- Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort.
- Body mass index (BMI) within the range of 18.5 to 30 kg/m^2 (inclusive) at the time of Screening.
- No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations.
- Participants with normal renal function.
- Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods.
Who cannot join
- Currently have an acute disease with active symptoms.
- History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.).
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias.
- History of clinically significant hypersensitivity reaction to any drugs or additives.
- History of any gastrointestinal disease.
- History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake.
Show all 19Show fewer
- Evidence of moderate or excessive alcohol consumption.
- Tested positive in viral serology tests (hepatitis B virus [HBV], hepatitis C virus [HCV], and human immunodeficiency virus [HIV]).
- Known family history or known presence of long QT syndrome.
- A history of hypokalemia.
- Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate).
- History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis.
- History of Multiple Endocrine Neoplasia type 2.
- Solid organ transplantation, except corneal transplants.
- History or presence of neutropenia which is defined as absolute neutrophil count (ANC) < 1.5 at Screening and admission.
- Participants with a microalbuminuria.
- Hemoglobin levels below 12.0 g/dL at Screening or Baseline.
- White Blood Cell levels below 3.5 × 109/L at Screening or Baseline.
- Platelet count < 150,000/µL, international normalized ratio (INR) > 1.5, albumin < 3.5 g/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical trials medical group/PAREXEL
Glendale, California, 91206
About this study
Official title: A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
- Conditions
- Healthy Participants
- Being tested
- ID119031166M, Placebo
- Keywords
- First-in-human (FIH), Single ascending doses (SAD), Multiple ascending doses (MAD), Farnesoid X receptor (FXR) agonist, Noncirrhotic non-alcoholic steatohepatitis (NASH), Liver fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID119031166MDrug
The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
PlaceboDrug
The participant will receive a oral dose of Placebo.
| Study group | Role | What they receive |
|---|---|---|
| SAD: ID119031166M | Experimental | Not described Receives: Drug: ID119031166M |
| MAD: ID119031166M | Experimental | Not described Receives: Drug: ID119031166M |
| SAD: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.
Measured: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)
Secondary outcomes (6)
Maximum plasma concentration determined directly from the concentration- time profile (Cmax)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Measured: Day 1-4 for SAD and Day 1-17 for MAD
Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Measured: Day 1-4 for SAD and Day 1-17 for MAD
Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Measured: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized Cmax
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Measured: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Measured: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC0-last
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Measured: Day 1-4 for SAD and Day 1-17 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start10 Oct 2022
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Why it stopped: Sponsor have decided to cancel the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, YUNOVIA CO.,LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604287
- Sponsor's protocol ID
- ID119031166M-NASH-101
- Status last verified
- Jul 2024
- First submitted
- 28 Oct 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants
- ClinicalTrials.gov ID
- NCT05604287
- Acronym / sponsor ID
- ID119031166M-NASH-101
- Conditions
- Healthy Participants
- Keywords
- First-in-human (FIH), Single ascending doses (SAD), Multiple ascending doses (MAD), Farnesoid X receptor (FXR) agonist, Noncirrhotic non-alcoholic steatohepatitis (NASH), Liver fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor have decided to cancel the trial
- Enrolment
- 67 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Parexel, YUNOVIA CO.,LTD.
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 3 Nov 2022 (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.
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD: ID119031166M | Experimental | Drug: ID119031166M |
| MAD: ID119031166M | Experimental | Drug: ID119031166M |
| SAD: Placebo | Placebo comparator | Drug: Placebo |
| MAD: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be Caucasian (White American of European or Latin American descent).
- Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort.
- Body mass index (BMI) within the range of 18.5 to 30 kg/m^2 (inclusive) at the time of Screening.
- No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations.
- Participants with normal renal function.
Key exclusion criteria (19 listed)
- Currently have an acute disease with active symptoms.
- History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.).
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias.
- History of clinically significant hypersensitivity reaction to any drugs or additives.
- History of any gastrointestinal disease.
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 |
|---|---|---|
| ID119031166MThe participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days. | Drug | MAD: ID119031166M, SAD: ID119031166M |
| PlaceboThe participant will receive a oral dose of Placebo. | Drug | MAD: Placebo, SAD: Placebo |
Primary outcome
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)
To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.
6 secondary outcomes
Maximum plasma concentration determined directly from the concentration- time profile (Cmax)
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized Cmax
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC0-last
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Results and safety
The study was stopped early (reason given: Sponsor have decided to cancel the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ID119031166M in people with Healthy Participants, run by IlDong Pharmaceutical Co Ltd at 1 site in United States.
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: Sponsor have decided to cancel the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) (time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)). 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 11 Jul 2024.