A Phase I randomized study of IMSB301 in healthy volunteers
- Conditions
- Healthy male and female adultsNot Applicable
- Registration Number
- ISRCTN90049550
- Lead Sponsor
- ImmuneSensor Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 64
1. Healthy male or female subjects between 18 and 55 years of age, inclusive
2. Signed informed consent and mental capability to understand the informed consent
3. Body mass index (BMI) between 18 and 33 kg/m2, inclusive, and a total body weight >45 kg for females and >50 kg for males
4. Unremarkable physical exam, normal vitals, and all laboratory values must be within normal limits or any abnormalities deemed not clinically significant by the Investigator at screening
5. Electrocardiogram (ECG) without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator
6. Negative test for drugs of abuse or alcohol at screening and Day -1
7. Women of childbearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1
8. Male and female subjects with reproductive potential must agree to use highly effective contraception throughout the study and for at least 3 months after the last study drug dose
9. Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures
1. Resting 12-lead ECG showing confirmed prolongation of corrected QT (QTc) (Fridericia’s correction) interval (QTc interval >470 for females and >450 for males)
2. Ongoing illness including, but not limited to, congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, clinically significant hypertension, or psychiatric illness/social situations that in the opinion of the Investigator would limit compliance with study requirements.
3. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
4. Have any of the following infectious risks:
4.1. Evidence of active infection during screening or Day -1 that in the opinion of the Investigator would pose an unacceptable risk for participating in the study
4.2. Symptomatic herpes zoster infection within 12 weeks prior to the screening period
4.3. Positive hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis (TB) test at screening
4.4. Household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB
5. Blood or plasma donation within 30 days prior to Day -1.
6. Any clinically significant illness in the 30 days prior to Day -1.
7. Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.
8. Use of nicotine products within six months prior to screening.
9. Use of prescription drugs except hormonal contraception, or over-the-counter medication including paracetamol, within two weeks of Day -1
10. Prior receipt of investigational product in this trial.
11. Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -1.
12. History of any condition that might impair the subject’s ability to understand or comply with the requirements of the study or to provide informed consent.
13. Receipt of a vaccination within 3 weeks prior to Day -1.
14. Consumption of any foods or beverages known to modulate CYP enzymes activity (eg, St. John’s wort, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 72 hours prior to admission to the study site and throughout the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of single and multiple-dose orally administered IMSB301 in healthy adult participants, assessed with physical examination, vital signs (heart rate, blood pressure and body temperature), clinical laboratory tests (hematology, coagulation, biochemistry, and urinalysis), AEs and ECGs at screening, Day -1, Day 1, Day 2, Day 3 and Day 7 for SAD participants and at screening, Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 10 for MAD participants
- Secondary Outcome Measures
Name Time Method The pharmacokinetics (PK) profile of IMSB301 in plasma including the preliminary effect of a high-fat meal on PK, measured by comparing plasma concentration versus time profiles of IMSB301 from the analysis of plasma samples. PK parameters will be calculated for each participant on Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 (Day 2), 36 (Day 2) and 48 (Day 3) hours.