Inflammatory Bowel DiseasesPhase 1NCT06206811
Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants
A Phase 1 study testing OD-07656 in people with Inflammatory Bowel Diseases and Blau Syndrome, run by Odyssey Therapeutics, Inc. at 1 site in Australia.
Trial summary
First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, and pharmacodynamics (PD) of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Blau Syndrome, Crohn Disease
- What is being tested?
- OD-07656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Feb 2024to 25 Nov 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body Mass Index (BMI) within the range 18-32kg/m2 (inclusive)
- Female participants must be of nonchildbearing potential, defined as either surgically sterile (i.e., hysterectomy, bilateral salpingectomy, tubal ligation, or bilateral oophorectomy), OR be post-menopausal with at least 1 year of amenorrhea. Female participants must use barrier contraception to protect against the transfer of study drug in any body fluids from time of first dose and for at least 7 days after the last dose of study drug.
- Male participants must agree to use double barrier contraception (i.e. a condom and additional contraception for their female partner) when sexually active with a female partner of child-bearing potential from Screening until at least 90 days after the last dose of study drug (or be surgically sterile [i.e., vasectomy with documentation]); or remain abstinent from heterosexual intercourse [when this is in line with the preferred and usual lifestyle] from the time of admission to the clinical centre up to 90 days post last dose. Male participants should also agree not to donate sperm for the duration of the study and until at least 90 days after the last dose of study drug.
- Male participants who engage in intercourse with same sex partners are required to use barrier forms of contraception to protect against the transfer of study drug in any body fluids from time of first dose and for at least 7 days after the last dose of study drug.
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Females with child-bearing potential.
- Use of any medications (prescription or over-the-counter [OTC]) within 14 days of study drug administration; the use of cyclosporine or tacrolimus drugs is prohibited within 30 days prior to dosing and the use of biological therapies including but not limited to anti-tumour necrosis factor or anti-interleukin-6 drugs is prohibited within 60 days prior to dosing. An exception is made for limited amounts of paracetamol (acetaminophen) (up to a maximum of 4 g/ day) or ibuprofen (up to 1.2 g/day); the extent of nonsteroidal anti-inflammatory drug self-medication will be documented. Other exceptions will only be made if the rationale is clearly documented by the Investigator.
- Current use of any vitamins or herbal supplements.
- Use of hormone replacement therapy, oral contraceptives, intrauterine hormonal contraception within 30 days of screening, or injectable hormonal contraception within 3 months of screening.
- Any vaccination with vaccines will be prohibited during study as well as within 30 days prior to (first) dosing in the study and within 30 days after the follow up visit.
- History of drug/chemical/alcohol abuse within 6 months prior to Screening. History of alcohol consumption of > 21 units per week for males and > 14 units per week for females within 6 months prior to Check-in. In addition, no alcohol to be consumed within 24 hours of screening or Check-in. One unit of alcohol equals 1 pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
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- Positive alcohol breath test result or positive urine drug screen at Screening or Check-in.
- Consumption of excessive xanthine (e.g. more than 8 cups of coffee or equivalent per day) within 1 month prior to screening.
- History of serious bacterial, viral, fungal, or parasitic infection, including but not limited to viral hepatitis (hepatitis B or C or hepatitis caused by cytomegalovirus [CMV] or Epstein-Barr virus [EBV]), tuberculosis or Toxoplasma (T.) gondii in the past 5 years.
- History of varicella zoster (chicken pox) or herpes zoster (shingles) in the past 5 years.
- History of known or suspected immunodeficiency state or condition that would compromise the participant's immune status, or any factor that would pre-dispose the participant to develop an infection, including but not limited to human immunodeficiency virus (HIV).
- Positive test for SARS-CoV-2 at Check-in.
- Recent or ongoing infection, such as current evidence of ongoing or acute infection, history of repeated, chronic or opportunistic infections (e.g., recurrent folliculitis, other cutaneous infections or repeated pneumonia) or history of a serious bacterial infection within 6 months prior to dosing.
- Positive hepatitis panel as defined by positive Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody.
- History of anaemia or any known or suspected condition that could be complicated by anaemia, or pre-dispose a participant to anaemia. Volunteers who have a history of iron deficiency anaemia for which a cause was identified and known not to be an ongoing concern (e.g. single episode of blood loss) and whose iron stores have fully recovered may be included. Participants will be excluded if haemoglobin is less than 12 g/dL.
- ECG abnormalities in the resting ECG defined as:
- A corrected QT interval by Fredericia (QTcF) >450 msec for males and QTcF > 470 for females;
- QRS >120 msec;
- Personal or family history of congenital long QT syndrome or sudden death;
- ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U-waves);
- Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal at Screening or Check-in.
- Use of more than 5 cigarettes/day (or equivalent amount of chewing tobacco, e-cigarettes or nicotine patches) after Screening until Check-in. No smoking is allowed during confinement.
- Have participated in another clinical trial within 3 months prior to screening.
- Have donated blood within 4 weeks prior to screening.
- Not willing and/or unable to consume investigational product that contains bovine and/or porcine products, or has a known or suspected allergy or hypersensitivity to bovine and/or porcine products.
- Evidence of any active or chronic disease or condition that could interfere with, or which the treatment of the disease might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the Investigator (following a detailed medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory parameters). This includes a history or presence of any disease (e.g. malignancy), condition, or surgery (e.g., cholecystectomy or stomach operation) likely to affect drug absorption, distribution, metabolism, or excretion. Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator as clinically irrelevant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Four-part, Phase 1, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) with Single and Multiple Ascending Oral Doses of OD-07656 in Healthy, Adult Male and Female Participants
First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, and pharmacodynamics (PD) of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating inflammatory bowel disease (IBD) (including Crohn's disease and ulcerative colitis), Blau syndrome, and spondyloarthritis
- Conditions
- Inflammatory Bowel Diseases, Blau Syndrome, Crohn Disease, Ulcerative Colitis, Spondyloarthritis
- Being tested
- OD-07656
- Medical subject headings
- Inflammatory Bowel Diseases, Blau syndrome, Crohn Disease, Colitis, Ulcerative, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OD-07656Drug
innate immune modulator
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Single Ascending dose | Experimental | To assess the safety and tolerability of single ascending doses of OD-07656 administered as an oral capsule Receives: Drug: OD-07656 |
| Part 2 - Multiple Ascending dose | Experimental | To assess the safety and tolerability of multiple ascending doses of OD-07656 administered as an oral capsule Receives: Drug: OD-07656 |
| Part 3 - Food effect and relative bioavailability between dose forms | Experimental | To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet Receives: Drug: OD-07656 |
| Part 4 - Pharmacokinetic drug interaction between midazolam and OD-07656 | Experimental | To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet following administration of midazolam Receives: Drug: OD-07656 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event assessed by Safety review committee
reported SAEs and AEs
Measured: approximately not less than 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start12 Feb 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odyssey Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Opipari, MD, PhD, Study chair, Odyssey Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206811
- Sponsor's protocol ID
- OD-07656-001
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2023
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-part, Phase 1, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) with Single and Multiple Ascending Oral Doses of OD-07656 in Healthy, Adult Male and Female Participants
- ClinicalTrials.gov ID
- NCT06206811
- Acronym / sponsor ID
- OD-07656-001
- Conditions
- Inflammatory Bowel Diseases, Blau Syndrome, Crohn Disease, Ulcerative Colitis, Spondyloarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Odyssey Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 16 Jan 2024 (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.
First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, and pharmacodynamics (PD) of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating inflammatory bowel disease (IBD) (including Crohn's disease and ulcerative colitis), Blau syndrome, and spondyloarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Single Ascending dose | Experimental | Drug: OD-07656To assess the safety and tolerability of single ascending doses of OD-07656 administered as an oral capsule |
| Part 2 - Multiple Ascending dose | Experimental | Drug: OD-07656To assess the safety and tolerability of multiple ascending doses of OD-07656 administered as an oral capsule |
| Part 3 - Food effect and relative bioavailability between dose forms | Experimental | Drug: OD-07656To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet |
| Part 4 - Pharmacokinetic drug interaction between midazolam and OD-07656 | Experimental | Drug: OD-07656To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet following administration of midazolam |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body Mass Index (BMI) within the range 18-32kg/m2 (inclusive)
- Female participants must be of nonchildbearing potential, defined as either surgically sterile (i.e., hysterectomy, bilateral salpingectomy, tubal ligation, or bilateral oophorectomy), OR be post-menopausal with at least 1 year of amenorrhea. Female participants must use barrier contraception to protect against the transfer of study drug in any body fluids from time of first dose and for at least 7 days after the last dose of study drug.
- Male participants must agree to use double barrier contraception (i.e. a condom and additional contraception for their female partner) when sexually active with a female partner of child-bearing potential from Screening until at least 90 days after the last dose of study drug (or be surgically sterile [i.e., vasectomy with documentation]); or remain abstinent from heterosexual intercourse [when this is in line with the preferred and usual lifestyle] from the time of admission to the clinical centre up to 90 days post last dose. Male participants should also agree not to donate sperm for the duration of the study and until at least 90 days after the last dose of study drug.
- Male participants who engage in intercourse with same sex partners are required to use barrier forms of contraception to protect against the transfer of study drug in any body fluids from time of first dose and for at least 7 days after the last dose of study drug.
Key exclusion criteria (27 listed)
- Females with child-bearing potential.
- Use of any medications (prescription or over-the-counter [OTC]) within 14 days of study drug administration; the use of cyclosporine or tacrolimus drugs is prohibited within 30 days prior to dosing and the use of biological therapies including but not limited to anti-tumour necrosis factor or anti-interleukin-6 drugs is prohibited within 60 days prior to dosing. An exception is made for limited amounts of paracetamol (acetaminophen) (up to a maximum of 4 g/ day) or ibuprofen (up to 1.2 g/day); the extent of nonsteroidal anti-inflammatory drug self-medication will be documented. Other exceptions will only be made if the rationale is clearly documented by the Investigator.
- Current use of any vitamins or herbal supplements.
- Use of hormone replacement therapy, oral contraceptives, intrauterine hormonal contraception within 30 days of screening, or injectable hormonal contraception within 3 months of screening.
- Any vaccination with vaccines will be prohibited during study as well as within 30 days prior to (first) dosing in the study and within 30 days after the follow up visit.
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 |
|---|---|---|
| OD-07656innate immune modulator | Drug | Part 1 - Single Ascending dose, Part 2 - Multiple Ascending dose, Part 3 - Food effect and relative bioavailability between dose forms, Part 4 - Pharmacokinetic drug interaction between midazolam and OD-07656 |
Primary outcome
Adverse event assessed by Safety review committee
Time frame: approximately not less than 1 month
reported SAEs and AEs
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 21 Feb 2025.
- 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. This study is not recruiting at the moment.
Anthony Opipari, MD, PhD study chair
Odyssey Therapeutics, Inc.
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 OD-07656 in people with Inflammatory Bowel Diseases and Blau Syndrome, run by Odyssey Therapeutics, Inc. at 1 site in Australia.
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 27 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 21 Feb 2025. 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 Australia. 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. 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?
Adverse event assessed by Safety review committee (time frame: approximately not less than 1 month). 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 21 Feb 2025.