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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06206811




Registration number
NCT06206811
Ethics application status
Date submitted
20/12/2023
Date registered
16/01/2024
Date last updated
4/03/2024

Titles & IDs
Public title
Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants
Scientific 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
Secondary ID [1] 0 0
OD-07656-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Blau Syndrome 0 0
Crohn Disease 0 0
Ulcerative Colitis 0 0
Spondyloarthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OD-07656

Experimental: Part 1 - Single Ascending dose - To assess the safety and tolerability of single ascending doses of OD-07656 administered as an oral capsule

Experimental: Part 2 - Multiple Ascending dose - To assess the safety and tolerability of multiple ascending doses of OD-07656 administered as an oral capsule

Experimental: Part 3 - Food effect and relative bioavailability between dose forms - To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet

Experimental: Part 4 - Pharmacokinetic drug interaction between midazolam and OD-07656 - To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet following administration of midazolam


Treatment: Drugs: OD-07656
innate immune modulator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse event assessed by Safety review committee
Timepoint [1] 0 0
approximately not less than 1 month

Eligibility
Key inclusion criteria
1. Participants who are overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, and cardiac monitoring.

2. Body Mass Index (BMI) within the range 18-32kg/m2 (inclusive)

3. 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.

4. 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.

5. 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.

6. 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
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Females with child-bearing potential.

2. 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.

3. Current use of any vitamins or herbal supplements.

4. Use of hormone replacement therapy, oral contraceptives, intrauterine hormonal
contraception within 30 days of screening, or injectable hormonal contraception within
3 months of screening.

5. 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.

6. 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.

7. Positive alcohol breath test result or positive urine drug screen at Screening or
Check-in.

8. Consumption of excessive xanthine (e.g. more than 8 cups of coffee or equivalent per
day) within 1 month prior to screening.

9. 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.

10. History of varicella zoster (chicken pox) or herpes zoster (shingles) in the past 5
years.

11. 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).

12. Positive test for SARS-CoV-2 at Check-in.

13. 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.

14. Positive hepatitis panel as defined by positive Hepatitis B surface antigen, Hepatitis
B core antibody, or Hepatitis C antibody.

15. 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.

16. ECG abnormalities in the resting ECG defined as:

1. A corrected QT interval by Fredericia (QTcF) >450 msec for males and QTcF > 470
for females;

2. QRS >120 msec;

3. Personal or family history of congenital long QT syndrome or sudden death;

4. 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);

5. Evidence of atrial fibrillation, atrial flutter, complete branch block,
Wolf-Parkinson-White Syndrome, or cardiac pacemaker.

17. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than
1.5 times the upper limit of normal at Screening or Check-in.

18. 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.

19. Have participated in another clinical trial within 3 months prior to screening.

20. Have donated blood within 4 weeks prior to screening.

21. 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.

22. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Odyssey Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 inflammatory bowel disease (IBD) (including Crohn's
disease and ulcerative colitis), Blau syndrome, and spondyloarthritis
Trial website
https://clinicaltrials.gov/ct2/show/NCT06206811
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeremy Sokolove
Address 0 0
Odyssey Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anthony Opipari
Address 0 0
Country 0 0
Phone 0 0
(617) 865-9628
Fax 0 0
Email 0 0
studyinfo@odysseytx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06206811