Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants

NCT06206811 | Completed Phase 1

• 1 other identifier: OD-07656-001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases; Blau Syndrome; Crohn Disease; Ulcerative Colitis; Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Adverse event assessed by Safety review committee

  reported SAEs and AEs

  approximately not less than 1 month

Study Arms (4)

Part 1 - Single Ascending dose

EXPERIMENTAL

To assess the safety and tolerability of single ascending doses of OD-07656 administered as an oral capsule

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

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

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

Drug: OD-07656

Interventions

OD-07656 DRUG

innate immune modulator

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Odyssey Therapeutics: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Blau syndrome; Crohn Disease; Colitis, Ulcerative; Spondylarthritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Anthony Opipari, MD, PhD

  Odyssey Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 16, 2024
• Study Start: February 12, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)