Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2023-01-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I, First-in-Human study in healthy participants, performed at a single study center, consisting of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria

• Healthy male and female (of non-childbearing potential) subjects aged 18 to 45 years, inclusive, with suitable veins for cannulation or repeated venipuncture.

• Female subjects must have a negative pregnancy test.

• Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

• Male subjects and their women of childbearing potential partners must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child from the first day of dosing until 15 days after the last dose of Investigational medicinal product.

Exclusion Criteria

• History of any clinically important disease or disorder, or a major medical/surgical procedure or significant trauma within 4 weeks of the first dose of IMP.

• Untreated tuberculosis (TB) or a positive result for the interferon gamma release assay (ie, QuantiFERON TB Gold).

• A positive result for serum hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody, at the Screening Visit.

• Ongoing acquired or inherited immunodeficiency disorders, including but not limited to HIV or common variable immunodeficiency, or the subject is taking immune replacement therapy.

• Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) within 30 days of screening.

• History of severe COVID-19 infection requiring hospitalization within the last 12 months prior to Screening, or clinical history compatible with Long COVID 19 (symptoms beyond 12 weeks of acute infection).

• Confirmed COVID-19 infection during Screening and/or admission by reverse transcription polymerase chain reaction (RT-PCR) test.

• History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed.

• History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.

• History of a traumatic fracture within 6 months of the Screening visit.

• A Bone density scans (DEXA scan) bone mineral density value with T-score < -1 for post-menopausal women and Z score < -1.5 for male participants and premenopausal women of non-childbearing potential subjects (MAD cohorts only).

• Has received live or live attenuated vaccine in the 30 days prior to dosing, the first dose of COVID-19 vaccine within 30 days prior to randomization, or a COVID 19 vaccine second or booster vaccination within 10 days of screening.

• Ongoing acute gastrointestinal (GI) disease, a history of chronic GI disease, ongoing acute hepatic disease, or a history of chronic hepatic disease, chronic renal disease, pancreatic disease, diabetes mellitus, or any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

• History of Gilbert's syndrome.

• History of muscle disease or rhabdomyolysis.

• Any laboratory values with the deviations at the Screening Visit and/or Day -1 from the reference range.

• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis.

• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG that may interfere with the interpretation of QTc interval changes, including abnormal ST wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.

• Known or suspected history of drug abuse.

• Current smokers who smoke > 5 cigarettes/e-cigarette/pipes per week or use of any tobacco in any other form.

• History of alcohol abuse or excessive intake of alcohol within 6 months prior to screening.

• Positive screen for drugs of abuse or alcohol at screening or admission.

• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.

• Plasma donation within 1 month of Screening or any blood donation/loss > 500 mL within 3 months of Screening.

• Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), HRT (for females), herbal remedies, mega dose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.

• Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.

• Excessive intake of high caffeine-containing drinks or food (eg, coffee, tea, energy drinks).

• Has received another new chemical entity (defined as a compound that has not been approved for marketing) within 3 months of the first administration of IMP in this study.

• Subjects who are vegans or have medical dietary restrictions.