A Phase 1, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of intravenously infused IB409 in healthy adult participants

Exclusion Criteria26

• Regular smokers (more than 2 cigarettes per day, or more than 10 cigarettes per week, or the equivalent e.g., vaping products such as e-cigarettes)
• Known hypersensitivity, allergy, or intolerance to the study intervention, or any of the excipients contained in the intervention formulation. If any history of anaphylaxis or infusion reaction to other agents, discussion with (and approval by) the PI, Medical Monitor and Sponsor is required.
• Any concomitant disease, condition or treatment which according to the PI (or qualified designee), places the participant at unacceptable risk if they were to participate in the study or may confound the ability to interpret data from the study.
• The participant has a medical history of, or a positive blood test for, human immunodeficiency virus (HIV; anti-HIV1 and anti-HIV2 antibodies), hepatitis C virus (HCV, anti-HCV antibodies), or hepatitis B surface antigen (HBsAg) at screening.
• History of immunological or autoimmune disorders, or acquired/congenital immunodeficiency, including autoimmune rheumatic diseases. This also includes any acute infections (including viral infections requiring prescribed medical treatment or isolation) occurring during screening or within 3 months prior to the start of screening. Note: Participants with mild asthma that is controlled with occasional use of a rescue inhaler (no chronic therapy, daily preventative therapy or inhaled corticosteroids) and those with mild atopic dermatitis managed with use of topical emollients only (no topical corticosteroids) may be considered for study participation at the PI’s discretion.
• Immunization with any live vaccine within 6 weeks prior to administration of study intervention; or expected to require any live vaccines during the study or within 6 weeks after receiving the study intervention.
• Acute or febrile illness within 7 days prior to the first dose of study intervention or participants with evidence of active infection.
• Poorly controlled hypertension defined as: average systolic BP greater than 140 mmHg or diastolic BP greater than 90 mmHg in supine position after 5 minutes of rest, (an average of 3 readings at screening and baseline would not be required if 1 of 3 allowed attempts is within acceptable range; if acceptable in the first attempt, no more readings need to be taken).
• Abnormal cardiac conditions and ECG detected at screening or Day -1:
• a. The Corrected QT interval (QTc) of ECG greater than 450 msec for males and greater than 470 msec for females, or any QTc value considered clinically significant by the PI.
• b. Sustained (i.e., 3 independent measurements within 30 minutes) heart rate greater than 100 or less than 40 bpm after the participant has been at rest for 5 minutes.
• c. Personal history of congenital long QT syndrome or family history of congenital long QT or sudden cardiac death.
• Evidence of active or suspected cancer, or a history of malignancy within the past 5 years, except for the following cases, that did not require systemic therapy and are considered cured: nonmelanoma skin cancer, or other in situ cancers.
• Any major surgery within 3 months before screening, or plan to have a surgery during the study period.
• Use of prescription medications within 14 days or 5 elimination half-lives (whichever is longer) of study intervention administration. Use of herbal remedies within 7 days of study intervention administration. Use of standard OTC medication (including vitamins and supplements), prescription hormonal contraception may be allowed per PI discretion. In addition, participants who have been on hormone replacement therapy (HRT) for a period of at least 2 months prior to the start of screening will not be excluded from the study, provided the HRT regimen will remain unchanged during the conduct of the study.
• Previous participation in a study with an investigational drug or device therapy within 30 days or 5 elimination half-lives if known (whichever is longer) prior to administration of the study drug.
• History of substance abuse within 6 months prior to admission or a positive drug abuse test result on Screening and Day -1. A suspected false positive result may be verified by re-testing at the discretion of the PI (or qualified designee), with up to 1 false positive result permitted.
• History of alcohol consumption of greater than 21 units per week for males and greater than 14 units per week for females within 6 months prior to screening. One unit is equivalent to 10 g of alcohol which equals to a half-pint (about 240 mL) of beer, 1 glass (125 mL) of wine or 1 (30 mL) measure of spirits.
• Positive alcohol breath test at screening and Day -1. An alcohol screen test result may be verified by re-testing at the discretion of the PI (or qualified designee), with up to 1 false positive result permitted.
• Unwilling to abstain from the consumption of caffeine and/or xanthine containing products (e.g., coffee, tea, chocolate, and caffeine containing sodas, etc.) that may influence metabolism of the drug from 72 hours before administration of study drug on Day 1 through to discharge from the CRU.
• Unwillingness to refrain from unaccustomed physical activity (e.g., heavy lifting, weight or fitness training) from 72 hours prior to admission on Day -1 through to discharge from the CRU, and in the 24 hours prior to each study visit where safety laboratory samples are scheduled for collection.
• Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 7 days prior to dosing with study drug and participant is unwilling to abstain from consumption of these products until after the final PK sample collection on Day 7 (+ 1 day).
• Female participants who are lactating.
• Pregnant participants (positive serum pregnancy test at the initial screening visit or positive urine pregnancy at D -1 [confirmed by serum test]) or planning to become pregnant within 90 days of screening.
• Receipt of blood products within 2 months prior to screening; donation (or loss) of 500 mL or more whole blood during the 30 days prior to first dosing, or donation of plasma or platelets during the 7 days prior to first dosing, and/or plan to donate whole blood, plasma or platelets within 4 weeks after the last study related blood draw.
• The participant is unwilling or unable to follow protocol requirements, including attendance at follow up visit(s), or otherwise unsuitable for study participation in the opinion of the PI.