Healthy ParticipantsPhase 1NCT05349097
Study to Evaluate IMG-004 in Healthy Participants
A Phase 1 study testing SAD IMG-004 30mg, SAD IMG-004 100mg and SAD IMG-004 200mg in people with Healthy Participants, run by Inmagene LLC at 1 site in United States.
Trial summary
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SAD IMG-004 30mg, SAD IMG-004 100mg and SAD IMG-004 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 2 May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and/or females, 18 to 60 years of age (inclusive) at the date of signed consent form.
- Body mass index (BMI) greater than or equal to 18.5 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus ensure use of effective contraception by their female partner of childbearing potential (ie, established use of hormonal contraception - started at least 30 days before Day 1; or placement or an intrauterine device or intrauterine system, diaphragm with spermicide or cervical sponge with spermicide) from screening and for at least 30 days after dosing and refrain from donating sperm during this period. Contraception requirements do not apply for participants in an exclusively same-sex relationship or if their female partner is of non-childbearing potential. Males with pregnant partners may participate if they agree to use a barrier method of contraception.
- Female participants of non-childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy, verbal confirmation through medical Confidential Page 17 of 75 history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL).
Who cannot join
- History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system, or other disease that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations or otherwise considered clinically significant.
- History of immunological abnormality (eg, primary or secondary immune suppression) that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations or otherwise considered clinically significant.
- History of severe immediate hypersensitivity reaction to BTK inhibitors, defined as non-cutaneous hypersensitivity reaction, requiring parenteral (IM/IV) therapy.
- Major surgery ≤ 4 weeks before Baseline visit. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
- History of malignancy or known current malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin.
- Participants who, in the Investigator's judgement, are perceived as having an increased risk of bleeding, eg, history of hemorrhagic disorders, clinical relevant petechial bleeding, occult blood in feces, hematuria in repeated urine tests(unless attributed to menstruation), trauma or surgery within the last month, planned surgery during trial participation, history of arteriovenous malformation or aneurysm, history of gastroduodenal ulcer disease or gastrointestinal hemorrhage, history of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding, use of drugs that may interfere with hemostasis during trial conduct (eg, acetylic salicylic acid or other non-steroidal anti-inflammatory drugs)
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- Participant has an active infection or history of infections as follows:
- Acute infection requiring treatment with oral antibiotics, anti-virals, anti-parasitics, anti-protozoal, or anti-fungals within 14 days before the Baseline visit.
- A serious infection, defined as requiring hospitalization or intravenous anti-microbial therapy within 2 months prior to Baseline visit.
- A history of opportunistic, recurrent, or chronic infections.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibody to Hepatitis B core antigen (HBcAb) with positive test for HBV DNA (> 500 IU/ml) or hepatitis C antibodies (HCV) at Screening visit.
- Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by the following:
- Positive Interferon Gamma Release Assay (IGRA) (with one of the following acceptable assays: QuantiFERON(R)-TB Gold (QFT-G) test, T-SPOT TB, QuantiFERON-TB Gold In-Tube test (QFT-GIT)) performed during Screening or within 3 months prior to Day 1. OR
- History of either untreated or inadequately treated latent or active TB infection.
- Participants with positive testing for COVID-19 at the Baseline visit.
- Participants with clinically significantly abnormal laboratory values, as determined by the Investigator (or medically qualified designee), including but not limited to:
- Absolute neutrophil count ≤ 1,500/μL or absolute lymphocyte count ≤ 800/μL, or eosinophil count > 700/μL, platelet counts < 100 × 109/L, hemoglobin < ULN, or any abnormal evaluations judged clinically significant by the Investigator (or medically qualified designee) at the Screening or Baseline visits. A single repeat of laboratory tests is permissible at Screening and Baseline, if deemed required by PI or medically qualified designee.
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≥ values of more than 1.5 times the upper limit of normal (ULN), which remains similar upon repeat, at the Screening or Baseline visits.
- Total bilirubin above ULN, which remains similar upon repeat, at the Screening or Baseline visits.
- Participants with Creatinine clearance rate < 80 mL/min as determined by the Cockcroft Gault formula, which remains similar upon repeat, at the Screening or Baseline visits.
- Closure time testing or platelet aggregometry testing (to monitor platelet function) outside of reference range at Screening or Baseline visit.
- QTcF greater than 450 msec (males) or greater than 470 msec (females) at Screening or Baseline visit (if out of range, repeat twice and average the 3 readings for eligibility purposes) or deemed clinically significant by the Investigator (or medically qualified designee).
- Screening ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement as judged by the Investigator (or medically qualified designee).
- Clinically significant abnormal screening values in clinical (electrocardiograms [ECGs], vital signs, physical examination) and laboratory tests in the opinion of the Investigator (or medically qualified designee). Up to two repeats of assessments or tests can be conducted at the discretion of the Investigator (or medically qualified designee).
- Use of any prescription medication within the 14 days prior to the first study drug administration or five half-lives, whichever is longer.
- Use of over-the-counter medication within 7 days prior to the first study drug administration, including herbal medicines, that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations.
- Average alcohol consumption of more than 14 units/week for females and 21 units/week for males (1 unit = one half-pint beer, 25 mL of 40% spirit or a 125-mL glass of wine).
- Use of more than 5 tobacco/nicotine-containing products per month within 6 months prior to the IMP administration.
- History of, or current substance abuse considered significant by the Investigator (or medically qualified designee) or positive urine drug and alcohol breath (or urine alcohol) testing at the Screening or Baseline visits.
- Live (attenuated) vaccination within 8 weeks before Screening visit or plan to be vaccinated by live (attenuated) vaccine during the trial (until completion of the final follow-up visit).
- COVID-19 vaccination, or influenza vaccination (inactivated), within 14 days prior to IMP administration or planning to receive COVID-19 vaccination or influenza vaccination (inactivated) within 14 days post IMP administration.
- Receipt of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to Day 1 dosing.
- Donated or lost more than 500 mL of blood or plasma within 3 months of the Screening visit or received blood products within 8 weeks of the Screening visit.
- Participant has a disease that might affect drug absorption, distribution, metabolism, and excretion based on the Investigator (or medically qualified designee)'s judgement (eg, gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery [except appendectomy and uncomplicated hernia repair], etc.)
- Cannot communicate adequately in English or cannot commit to full participation in all trial procedures.
- Pregnant or lactating women.
- Inability to comply with dietary regimen of the trial site.
- Any other circumstances that, in the Investigator (or medically qualified designee)'s judgment, may increase the risk associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants
Read the detailed description
The study is a Phase 1, randomized, double-blind, placebo-controlled study of orally administered IMG-004 to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses in healthy participants, in which 8 dosing cohort levels are planned to be evaluated. Food Effect of IMG-004 will also be evaluated in single oral dose of IMG-004 in healthy participants
- Conditions
- Healthy Participants
- Being tested
- SAD IMG-004 30mg, SAD IMG-004 100mg, SAD IMG-004 200mg, SAD IMG-004 400mg, SAD IMG-004 600mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAD IMG-004 30mgDrug
Each participant will be randomized to receive a single oral dose of 30mg IMG-004
SAD IMG-004 100mgDrug
Each participant will be randomized to receive a single oral dose of 100mg IMG-004
SAD IMG-004 200mgDrug
Each participant will be randomized to receive a single oral dose of 200mg IMG-004
SAD IMG-004 400mgDrug
Each participant will be randomized to receive a single oral dose of 400mg IMG-004
SAD IMG-004 600mgDrug
Each participant will be randomized to receive a single oral dose of 600mg IMG-004
SAD Placebo 30mgDrug
Each participant will be randomized to receive a single oral dose of 30mg matching placebo
SAD Placebo 100mgDrug
Each participant will be randomized to receive a single oral dose of 100mg matching placebo
SAD Placebo 200mgDrug
Each participant will be randomized to receive a single oral dose of 200mg matching placebo
SAD Placebo 400mgDrug
Each participant will be randomized to receive a single oral dose of 400mg matching placebo
SAD Placebo 600mgDrug
Each participant will be randomized to receive a single oral dose of 600mg matching placebo
MAD IMG-004 50mgDrug
Each participant will be randomized to receive daily oral dose of 50mg IMG-004 for 10 days
MAD Placebo 50mgDrug
Each participant will be randomized to receive daily oral dose of 50mg matching placebo for 10 days
MAD IMG-004 150mgDrug
Each participant will be randomized to receive daily oral dose of 150mg IMG-004 for 10 days
MAD Placebo 150mgDrug
Each participant will be randomized to receive daily oral dose of 150mg matching placebo for 10 days
MAD IMG-004 300mgDrug
Each participant will be randomized to receive daily oral dose of 300mg IMG-004 for 10 days
MAD Placebo 300mgDrug
Each participant will be randomized to receive daily oral dose of 300mg matching placebo for 10 days
FE IMG-004 150mgDrug
A single dose of IMG-004 at 150 mg dose level will be administered to the participants in fed and fasted states
| Study group | Role | What they receive |
|---|---|---|
| SAD cohort 1 active treatment | Experimental | 30mg Receives: Drug: SAD IMG-004 30mg |
| SAD cohort 2 active treatment | Experimental | 100mg. Receives: Drug: SAD IMG-004 100mg |
| SAD cohort 3 active treatment | Experimental | 200mg Receives: Drug: SAD IMG-004 200mg |
| SAD cohort 4 active treatment | Experimental | 400mg. Receives: Drug: SAD IMG-004 400mg |
| SAD cohort 5 active treatment | Experimental | 600mg. Receives: Drug: SAD IMG-004 600mg |
| SAD cohort 1 placebo | Placebo comparator | 30mg Receives: Drug: SAD Placebo 30mg |
| SAD cohort 2 placebo | Placebo comparator | 100mg. Receives: Drug: SAD Placebo 100mg |
| SAD cohort 3 placebo | Placebo comparator | 200mg. Receives: Drug: SAD Placebo 200mg |
| SAD cohort 4 placebo | Placebo comparator | 400mg. Receives: Drug: SAD Placebo 400mg |
| SAD cohort 5 placebo | Placebo comparator | 600mg. Receives: Drug: SAD Placebo 600mg |
| MAD cohort 1 active treatment | Experimental | 50mg Receives: Drug: MAD IMG-004 50mg |
| MAD cohort 1 placebo | Placebo comparator | 50mg Receives: Drug: MAD Placebo 50mg |
| MAD cohort 2 active treatment | Experimental | 150mg Receives: Drug: MAD IMG-004 150mg |
| MAD cohort 2 placebo | Placebo comparator | 150mg Receives: Drug: MAD Placebo 150mg |
| MAD cohort 3 active treatment | Experimental | 300mg Receives: Drug: MAD IMG-004 300mg |
| MAD cohort 3 placebo | Placebo comparator | 300mg Receives: Drug: MAD Placebo 300mg |
| Food Effect cohort | Experimental | 150mg Receives: Drug: FE IMG-004 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of IMG-004
Incidence and severity of AEs, including clinically relevant findings from vital signs, physical examination, laboratory tests, and 12-lead ECG
Measured: SAD cohort from signing ICF up to Day 15; MAD cohort: from signing ICF to Day24
Secondary outcomes (1)
PK parameters of IMG-004
Single Dose: Cmax, Tmax, AUClast, etc. Multiple dose: Cmax-ss), Tmax-ss, AUCss, etc.
Measured: SAD cohort from day 1 to day 8, MAD cohort from day 1 to day 17, FE cohort from day 1 to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start8 Aug 2022
- Primary completion2 May 2024
- Study completion2 May 2024
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmagene LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349097
- Sponsor's protocol ID
- IMG-004-101
- Status last verified
- May 2024
- First submitted
- 17 Apr 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants
- ClinicalTrials.gov ID
- NCT05349097
- Acronym / sponsor ID
- IMG-004-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 27 Apr 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.
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants
Detailed description
The study is a Phase 1, randomized, double-blind, placebo-controlled study of orally administered IMG-004 to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses in healthy participants, in which 8 dosing cohort levels are planned to be evaluated. Food Effect of IMG-004 will also be evaluated in single oral dose of IMG-004 in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| SAD cohort 1 active treatment | Experimental | Drug: SAD IMG-004 30mg30mg |
| SAD cohort 2 active treatment | Experimental | Drug: SAD IMG-004 100mg100mg. |
| SAD cohort 3 active treatment | Experimental | Drug: SAD IMG-004 200mg200mg |
| SAD cohort 4 active treatment | Experimental | Drug: SAD IMG-004 400mg400mg. |
| SAD cohort 5 active treatment | Experimental | Drug: SAD IMG-004 600mg600mg. |
| SAD cohort 1 placebo | Placebo comparator | Drug: SAD Placebo 30mg30mg |
| SAD cohort 2 placebo | Placebo comparator | Drug: SAD Placebo 100mg100mg. |
| SAD cohort 3 placebo | Placebo comparator | Drug: SAD Placebo 200mg200mg. |
| SAD cohort 4 placebo | Placebo comparator | Drug: SAD Placebo 400mg400mg. |
| SAD cohort 5 placebo | Placebo comparator | Drug: SAD Placebo 600mg600mg. |
| MAD cohort 1 active treatment | Experimental | Drug: MAD IMG-004 50mg50mg |
| MAD cohort 1 placebo | Placebo comparator | Drug: MAD Placebo 50mg50mg |
| MAD cohort 2 active treatment | Experimental | Drug: MAD IMG-004 150mg150mg |
| MAD cohort 2 placebo | Placebo comparator | Drug: MAD Placebo 150mg150mg |
| MAD cohort 3 active treatment | Experimental | Drug: MAD IMG-004 300mg300mg |
| MAD cohort 3 placebo | Placebo comparator | Drug: MAD Placebo 300mg300mg |
| Food Effect cohort | Experimental | Drug: FE IMG-004 150mg150mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males and/or females, 18 to 60 years of age (inclusive) at the date of signed consent form.
- Body mass index (BMI) greater than or equal to 18.5 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus ensure use of effective contraception by their female partner of childbearing potential (ie, established use of hormonal contraception - started at least 30 days before Day 1; or placement or an intrauterine device or intrauterine system, diaphragm with spermicide or cervical sponge with spermicide) from screening and for at least 30 days after dosing and refrain from donating sperm during this period. Contraception requirements do not apply for participants in an exclusively same-sex relationship or if their female partner is of non-childbearing potential. Males with pregnant partners may participate if they agree to use a barrier method of contraception.
- Female participants of non-childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy, verbal confirmation through medical Confidential Page 17 of 75 history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL).
Key exclusion criteria (38 listed)
- History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system, or other disease that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations or otherwise considered clinically significant.
- History of immunological abnormality (eg, primary or secondary immune suppression) that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations or otherwise considered clinically significant.
- History of severe immediate hypersensitivity reaction to BTK inhibitors, defined as non-cutaneous hypersensitivity reaction, requiring parenteral (IM/IV) therapy.
- Major surgery ≤ 4 weeks before Baseline visit. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
- History of malignancy or known current malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| SAD IMG-004 30mgEach participant will be randomized to receive a single oral dose of 30mg IMG-004 | Drug | SAD cohort 1 active treatment |
| SAD IMG-004 100mgEach participant will be randomized to receive a single oral dose of 100mg IMG-004 | Drug | SAD cohort 2 active treatment |
| SAD IMG-004 200mgEach participant will be randomized to receive a single oral dose of 200mg IMG-004 | Drug | SAD cohort 3 active treatment |
| SAD IMG-004 400mgEach participant will be randomized to receive a single oral dose of 400mg IMG-004 | Drug | SAD cohort 4 active treatment |
| SAD IMG-004 600mgEach participant will be randomized to receive a single oral dose of 600mg IMG-004 | Drug | SAD cohort 5 active treatment |
| SAD Placebo 30mgEach participant will be randomized to receive a single oral dose of 30mg matching placebo | Drug | SAD cohort 1 placebo |
| SAD Placebo 100mgEach participant will be randomized to receive a single oral dose of 100mg matching placebo | Drug | SAD cohort 2 placebo |
| SAD Placebo 200mgEach participant will be randomized to receive a single oral dose of 200mg matching placebo | Drug | SAD cohort 3 placebo |
| SAD Placebo 400mgEach participant will be randomized to receive a single oral dose of 400mg matching placebo | Drug | SAD cohort 4 placebo |
| SAD Placebo 600mgEach participant will be randomized to receive a single oral dose of 600mg matching placebo | Drug | SAD cohort 5 placebo |
| MAD IMG-004 50mgEach participant will be randomized to receive daily oral dose of 50mg IMG-004 for 10 days | Drug | MAD cohort 1 active treatment |
| MAD Placebo 50mgEach participant will be randomized to receive daily oral dose of 50mg matching placebo for 10 days | Drug | MAD cohort 1 placebo |
| MAD IMG-004 150mgEach participant will be randomized to receive daily oral dose of 150mg IMG-004 for 10 days | Drug | MAD cohort 2 active treatment |
| MAD Placebo 150mgEach participant will be randomized to receive daily oral dose of 150mg matching placebo for 10 days | Drug | MAD cohort 2 placebo |
| MAD IMG-004 300mgEach participant will be randomized to receive daily oral dose of 300mg IMG-004 for 10 days | Drug | MAD cohort 3 active treatment |
| MAD Placebo 300mgEach participant will be randomized to receive daily oral dose of 300mg matching placebo for 10 days | Drug | MAD cohort 3 placebo |
| FE IMG-004 150mgA single dose of IMG-004 at 150 mg dose level will be administered to the participants in fed and fasted states | Drug | Food Effect cohort |
Primary outcome
Safety of IMG-004
Time frame: SAD cohort from signing ICF up to Day 15; MAD cohort: from signing ICF to Day24
Incidence and severity of AEs, including clinically relevant findings from vital signs, physical examination, laboratory tests, and 12-lead ECG
1 secondary outcome
PK parameters of IMG-004
Time frame: SAD cohort from day 1 to day 8, MAD cohort from day 1 to day 17, FE cohort from day 1 to day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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 SAD IMG-004 30mg, SAD IMG-004 100mg and SAD IMG-004 200mg in people with Healthy Participants, run by Inmagene LLC 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 5 inclusion and 38 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: finished, as of the sponsor's last update on 17 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of IMG-004 (time frame: SAD cohort from signing ICF up to Day 15; MAD cohort: from signing ICF to Day24). 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 17 May 2024.