Aom0319 SAD Study in Healthy Subjects

NCT05555758 | Completed Phase 1

• 1 other identifier: Aom0319-ACT-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Only SAD study will be conducted in this project. SAD represents single ascending dose. Multiple ascending dose have been cancelled. This decision has been made at the discretion of the Sponsor.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs

  To evaluate the safety and tolerability of Aom0319 in healthy subjects

  8 days max

Secondary Outcomes (14)

• Maximum plasma concentration in plasma (Cmax)

  Day1-2 for SAD

• Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration in plasma (AUC0-t)

  Day1-2 for SAD

• Area under the concentration-time curve extrapolated from time 0 to infinity in plasma (AUC0-∞)

  Day1-2 for SAD

• AUC from time 0 to 12 hours (AUC0-12)

  Day1-2

• AUC from time 0 to 24 hours (AUC0-24)

  Day1-2

Study Arms (2)

experimental group

ACTIVE COMPARATOR

Four ascending dose levels of Aom0319 (n=24) for intravenous injection for once. Dosage day is Day 1.

Drug: Adamgammadex Sodium

placebo group

PLACEBO COMPARATOR

Four ascending dose levels of placebo (n=8) for intravenous injection for once. Dosage day is Day 1.

Drug: 0.9% Sodium Chloride Injection

Interventions

Adamgammadex Sodium DRUG

Aom0319 will be administered intravenously with water for injection.

Also known as: Aom0319

experimental group

0.9% Sodium Chloride Injection DRUG

0.9% Sodium Chloride will be administered intravenously.

Also known as: Placebo

placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects ≥18 years and ≤55 years of age on the day of ICF signing.
• Subjects must be White (participants from Europe, Middle East, North Africa, Australia, and New Zealand are permitted), with biological parents and both sets of biological grandparents also be White;
• Male subjects must have a body weight ≥50 kg and female subjects must have a body weight ≥45 kg. Body mass index (calculated as weight \[kg\]/height \[m\]2) must be ≥18.0 and ≤ 32.0 kg/m2;
• In good health, as determined by medical history, physical examination, clinical laboratory evaluation, 12-lead ECG, and vital signs (including oxygen saturation) within normal range or deemed by the investigator to be not clinically significant;
• Willing to use an adequate method of contraception, 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. Abstinence is an acceptable method of contraception provided it aligns with the preferred and usual lifestyle of the subject. Female subjects of nonchildbearing potential and subjects who are exclusively in same-sex relationships are exempt from contraception requirements. An adequate method of contraception is defined as:
• a)For female subjects, an adequate method of contraception is defined as the use of a condom by the male partner combined with the use of a highly effective method of contraception. The following are considered as highly effective methods of contraception: i)A nonhormonal intrauterine device; ii)Bilateral tubal occlusion (e.g. Essure-non-surgical sterility procedure and Bilateral tubal ligation), and/or a vasectomized partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner; b)For male subjects, an adequate method of contraception is defined as use of a condom combined with the use of a highly effective method of contraception by the female partner of childbearing potential. A highly effective method of contraception is i)Oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (e.g. Mirena) and progestogen-only hormonal contraception associated with inhibition of ovulation; ii)A hormonal or nonhormonal intrauterine device; iii)Bilateral tubal occlusion including bilateral tubal ligation, and/or a vasectomized subject with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner;
• Female subjects must be non-pregnant (confirmed by a negative serum \[at screening\] and urine \[on Day -1\] pregnancy test), non-lactating, or be of nonchildbearing potential (females who have been postmenopausal \[defined as 12 months of amenorrhea in the absence of other biological cause with confirmatory follicle stimulating hormone ≥40 IU/L\] for at least 12 consecutive months or are surgically sterile \[hysterectomy or bilateral oophorectomy or bilateral complete salpingectomy\]);
• Willing and able to freely given informed consent by signing the ICF.

You may not qualify if:

• 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 \[platelet count \< 150×109/L\] and prothrombin time-international normalized ratio \>1.5);
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥1.5 × the upper limit of normal at screening or check-in;
• Abnormal ECG results which are judged as clinically significant by the investigator, or any of the following:
• QTcF interval (calculated as QTc=QT/\[RR\^0.33\]) \>430 ms for male subjects and \> 450 ms for female subjects;
• Complete bundle branch block including left and/or right complete bundle branch block;
• Symptoms of acute or age variable myocardial infarction;
• ST-T changes suggestive of myocardial ischemia;
• First-degree (PR interval ≥200 ms), second-degree, or third-degree atrioventricular block;
• Abnormal blood pressure or heart rate (defined as systolic blood pressure \>140 mmHg or \<90 mmHg, diastolic blood pressure \>90 mmHg or \<50 mmHg, and heart rate \<45 bpm or \>100 bpm) during the study screening period and at check-in;
• Febrile illness or infection 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 reactive HIV antigen/antibody 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 test (QuantiFERON Gold);

Sponsors & Collaborators

• Amckaus PTY LTD.: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Australia

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kristi Mclendon, PhD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 27, 2022
• Study Start: December 15, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 21, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)