Aom0319 SAD/MAD Study in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study consists of two parts, Parts A and B. Part A includes a single ascending dose(SAD) study and a multiple ascending dose(MAD) study in healthy Caucasian subjects. Part B includes a single ascending dose(SAD) study and a multiple ascending dose(MAD) study in healthy Chinese subjects.

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

Details

• Lead Sponsor: Amckaus PTY LTD.

Criteria

Inclusion Criteria:

• Healthy male or female subjects ≥18 years (or the legal age of consent) and ≤55 years of age on the day of ICF signing.

1. Part A only: subjects must be Caucasian, with both biological parents and sets of biological grandparents also Caucasian.

2. Part B only: subjects must be Chinese, with both biological parents and sets of biological parents of Chinese descent. All biological grandparents must be born in China. Chinese subjects must be matched by body weight (in kg; ±20%), height (in cm; ±15%), and sex to a Caucasian subject in Group A2 (4 mg/kg dose level).

• Male subjects must have a body weight ≥50 kg and female subjects must have a body weight ≥45 kg. Body mass index (BMI; calculated as weight [kg]/height [m]2) must be ≥18.0 and 30.0 ≤ kg/m2;

• In good health, as determined by medical history, physical examination, clinical laboratory evaluation, 12-lead ECG, and vital signs various tests related to the trial within normal range or deemed by the investigator to be not clinically significant;

• Willing to use effective methods of contraception (except for steroid contraceptives which are not permitted), and do not plan to become pregnant, impregnate a partner, or donate sperm or ova throughout the study and for 3 months following the end of the study. Female subjects must be non-pregnant (confirmed by a negative serum pregnancy test), non-lactating, or be of non-childbearing potential (females who have been postmenopausal for at least 12 consecutive months or are surgically sterile, and are considered to be permanently sterile);

• Willing and able to freely given informed consent by signing the ICF.

Exclusion Criteria:

• History of hereditary bleeding disorders, coagulation disorders, non-traumatic bleeding requiring treatment, or thromboembolism; or currently have any disease that can cause bleeding (including coagulation disorder, thrombocytopenia [platelet count < 100×109/L] and PT-INR>1.5);

• Abnormal ECG results which are judged as clinically significant by the investigator, or any of the following:

1. QTcF interval (calculated as QTc=QT/[RR^0.33]) >430 ms for male subjects and > 450 ms for female subjects;

2. Complete bundle branch block;

3. Symptoms of acute or age variable myocardial infarction;

4. ST-T changes suggestive of myocardial ischemia;

5. First-degree(PR≥0.21s), second-degree, or third-degree atrioventricular block;

6. Severe bradycardia or tachycardia;

• Abnormal blood pressure or heart rate (defined as systolic blood pressure >140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg or <60 mmHg, and heart rate <60 bpm or >100 bpm) during the study screening period and at check-in, which are judged as clinically significant by the investigator;

• Febrile illness within 7 days prior to drug administration (Day 1);

• History of significant food or drug allergy or allergy history (including symptoms of allergic reaction, clinically significant skin diseases such as contact dermatitis or psoriasis, visible skin rashes, or asthma attacks during physical examination) which is judged as clinically significant by the investigator, or hypersensitivity to cyclodextrin;

• Subjects who have previously taken sugammadex sodium;

• Acute or chronic clinically significant infectious disease during the screening period or at check-in; or a positive hepatitis C antibody, human immunodeficiency virus antibody, hepatitis B surface antigen, or syphilis test at screening;

• History or manifestation of disease that, in the opinion of the investigator, renders the subject unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders;

• History of tuberculosis (TB) or related infection that is active, latent, or inadequately treated, or positive TB skin test;

• History of disseminated herpes zoster, disseminated herpes simplex, or recurrent localized cutaneous herpes zoster;

• Poor peripheral venous access, unable to tolerate venipuncture, or have a significant history of trypanaphobia or hemophobia;

• History of drug abuse within 6 months prior to screening;

• Use of drugs of abuse within 3 months prior to screening;

• Participation in a clinical study involving administration of an investigational drug product within 3 months prior to screening;

• Use of fusidic acid, toremifene citrate, tamoxifen citrate, clomiphene citrate, progesterone, norethisterone, testosterone, prednisone, other steroid hormones, or any drug which could affect the absorption or PK parameters of Aom0319 within 3 months prior to screening;

• Donation or loss of blood exceeding 200 mL of blood within 3 months prior to screening, plan to donate blood or blood components during the study period, or have previously received blood products;

• Use of prescription drugs, over-the-counter drugs, Chinese herbal medicines, dietary supplements, or natural health products (including vitamins, minerals, and phytotherapeutic, herbal, and plant-derived preparations) within 2 weeks prior to screening until check-in (Day -1); But allowing certain OTC medications within 7 days prior to dosing, e.g. paracetamol, ibuprofen etc.

• Administration of a vaccine within 4 weeks prior to screening or plan to be vaccinated during the study;

• Smoke more than 5 cigarettes per day within 3 months prior to screening or unable abstain from tobacco products during the study;

• Regularly consumption of more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or unable to abstain from alcohol for the duration of the study;

• Daily regularly consumption of tea, coffee, and/or caffeinated beverages exceeding 8 cups (where 1 cup = 250mL) within 3 months prior to screening. Subjects should not use chocolate-, caffeine-, or xanthine-containing products from screening through check-in (Day -1);

• Consumption of substances known to induce or inhibit liver metabolic enzymes (including grapefruit, mango, dragon fruit, grapes or grape juice, oranges or orange juice, and other products rich in flavonoids or citrus glycosides), strenuous activity, or other factors that could affect drug absorption, distribution, metabolism, and excretion from screening through check-in (Day -1);

• Failure to abstain from tobacco or alcohol products from screening to check-in Day -1;

• Female subjects who are pregnant or breastfeeding, who have a positive serum pregnancy test result, or who are unable or unwilling to take contraceptive measures approved by the investigator during the study;

• Considered unsuitable for inclusion in the study by the investigator.