Healthy VolunteersPhase 1NCT05555758
Aom0319 SAD Study in Healthy Subjects
A Phase 1 study testing Adamgammadex Sodium and 0.9% Sodium Chloride Injection in people with Healthy Volunteers, run by Amckaus PTY LTD. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Adamgammadex Sodium and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Dec 2022to 21 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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);
- History of disseminated herpes zoster, disseminated herpes simplex, recurrent localized cutaneous herpes zoster (including one episode of cutaneous herpes zoster);
- Poor peripheral venous access, unable to tolerate venipuncture, or have a significant history of trypanaphobia or hemophobia;
- History of substance abuse (including illicit drugs) within 6 months prior to dosing (Day 1);
- Use of drugs of abuse (including but not limited to amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxy-methamphetamine, phencyclidine, and tetrahydrocannabinol) within 3 months prior to dosing (Day 1), or positive drugs of abuse test at screening or Day -1;
- Those who have been dosed in a previous study or administration of an investigational drug within 1 month (or 5 half-lives, whichever is longer) prior to dosing (Day 1);
- Use of fusidic acid, toremifene citrate, tamoxifen citrate, clomiphene citrate, progesterone, norethisterone, testosterone, prednisone, combination contraceptives that contain steroid hormones such as progesterone, other steroid hormones, which could affect the absorption or PK parameters of Aom0319 within 7 days prior to dosing (Day 1) until discharge;
- Donation or loss of blood exceeding 500 mL of blood within 56 days prior to dosing (Day 1), plan to donate blood or blood components during the study period, or have previously received blood products;
- With the exception of those listed in exclusion criterion #16, 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) from 2 weeks prior to dosing (Day 1) until discharge;
- Administration of a vaccine within 4 weeks prior to dosing (Day 1) or plan to be vaccinated during the study;
- Smoke more than 5 cigarettes per day within 30 days prior to dosing (Day 1) or inability to abstain from tobacco- or nicotine-containing products during the study (from Day -1 to the follow up visit);
- Regular consumption of the amount of alcohol (in an Australian standard drink）of more than 2 standard drinks per day or 14 standard drinks per week within 3 months prior to check-in (Day -1; 1 standard drink is equivalent to 10 grams of alcohol: approximately 285 mL full-strength beer or cider[4.9% alc/vol], 375 ml mid-strength beer[3.5% alc/vol], 425ml light- strength beer[2.7% alc/vol], 100 mL wine or 30 mL shot of 40% spirit ). A positive alcohol breath test at screening or check-in (Day -1), or inability to abstain from alcohol during the study from check-in (Day -1) to the follow-up visit;
- Daily regular consumption of tea, coffee, and/or caffeinated beverages exceeding 8 cups (where 1 cup = 250 mL) within 3 months prior to dosing (Day 1) or consumption of chocolate-, caffeine-, or xanthine-containing products within 48 hours prior to dosing (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 that could affect drug absorption, distribution, metabolism, and excretion within 48 hours prior to dosing [Day 1]);
- Participation in strenuous activity within 48 hours prior to dosing (Day 1);
- Female subjects who are pregnant or breastfeeding, who have a positive serum or urine pregnancy test result, or who are unable or unwilling to take contraceptive or abstinence measures approved by the investigator during the study;
- History of constipation or the inability to maintain regular bowel movements at least once a day for the subjects of Group C2 within 3 months before administration;
- Considered unsuitable for inclusion in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics Profile of Aom0319 in Healthy White Subjects
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.
Read the detailed description
This study was designed to evaluate the safety and tolerability of Aom0319.
The trial is designed as follows.
- SAD: 32 participants will be studied in four groups with n = 8 (6 active: 2 placebo) per group.
- Conditions
- Healthy Volunteers
- Being tested
- Adamgammadex Sodium, 0.9% Sodium Chloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adamgammadex SodiumDrug
Also called Aom0319
Aom0319 will be administered intravenously with water for injection.
0.9% Sodium Chloride InjectionDrug
Also called Placebo
0.9% Sodium Chloride will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Active comparator | Four ascending dose levels of Aom0319 (n=24) for intravenous injection for once. Dosage day is Day 1. Receives: 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. Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 days max
Secondary outcomes (14)
Maximum plasma concentration in plasma (Cmax)
Pharmacokinetics
Measured: 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)
Pharmacokinetics
Measured: Day1-2 for SAD
Area under the concentration-time curve extrapolated from time 0 to infinity in plasma (AUC0-∞)
Pharmacokinetics
Measured: Day1-2 for SAD
AUC from time 0 to 12 hours (AUC0-12)
Pharmacokinetics
Measured: Day1-2
AUC from time 0 to 24 hours (AUC0-24)
Pharmacokinetics
Measured: Day1-2
Time of the maximum observed concentration in plasma (Tmax)
Pharmacokinetics
Measured: Day1-2 for SAD
Terminal elimination half-life in plasma (t1/2)
Pharmacokinetics
Measured: Day1-2 for SAD
Volume of distribution during the terminal phase in plasma (Vz)
Pharmacokinetics
Measured: Day1-2 for SAD
Total clearance in plasma (CL)
Pharmacokinetics
Measured: Day1-2 for SAD
Terminal elimination rate constant in plasma (λz)
Pharmacokinetics
Measured: Day1-2 for SAD
Mean residence time in plasma (MRT)
Pharmacokinetics
Measured: Day1-2 for SAD
Cumulative amount of dose recovered in urine from time 0 to 24 hours (Ae0-24)
Urine and faeces for PK
Measured: Day1-2
Cumulative percentage of dose recovered in urine from time 0 to 24 hours (fe0-24)
Urine and faeces for PK
Measured: Day1-2
Renal clearance in urine (CLr)
Urine and faeces for PK
Measured: Day1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start15 Dec 2022
- Primary completion13 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amckaus PTY LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristi Mclendon, PhD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555758
- Sponsor's protocol ID
- Aom0319-ACT-01
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics Profile of Aom0319 in Healthy White Subjects
- ClinicalTrials.gov ID
- NCT05555758
- Acronym / sponsor ID
- Aom0319-ACT-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Amckaus PTY LTD.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was designed to evaluate the safety and tolerability of Aom0319.
The trial is designed as follows.
- SAD: 32 participants will be studied in four groups with n = 8 (6 active: 2 placebo) per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Active comparator | Drug: Adamgammadex SodiumFour ascending dose levels of Aom0319 (n=24) for intravenous injection for once. Dosage day is Day 1. |
| placebo group | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionFour ascending dose levels of placebo (n=8) for intravenous injection for once. Dosage day is Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (32 listed)
- 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:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adamgammadex SodiumAlso: Aom0319Aom0319 will be administered intravenously with water for injection. | Drug | experimental group |
| 0.9% Sodium Chloride InjectionAlso: Placebo0.9% Sodium Chloride will be administered intravenously. | Drug | placebo group |
Primary outcome
The number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
Time frame: 8 days max
To evaluate the safety and tolerability of Aom0319 in healthy subjects
14 secondary outcomes
Maximum plasma concentration in plasma (Cmax)
Time frame: 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)
Time frame: Day1-2 for SAD
Area under the concentration-time curve extrapolated from time 0 to infinity in plasma (AUC0-∞)
Time frame: Day1-2 for SAD
AUC from time 0 to 12 hours (AUC0-12)
Time frame: Day1-2
AUC from time 0 to 24 hours (AUC0-24)
Time frame: Day1-2
Time of the maximum observed concentration in plasma (Tmax)
Time frame: Day1-2 for SAD
Terminal elimination half-life in plasma (t1/2)
Time frame: Day1-2 for SAD
Volume of distribution during the terminal phase in plasma (Vz)
Time frame: Day1-2 for SAD
Total clearance in plasma (CL)
Time frame: Day1-2 for SAD
Terminal elimination rate constant in plasma (λz)
Time frame: Day1-2 for SAD
Mean residence time in plasma (MRT)
Time frame: Day1-2 for SAD
Cumulative amount of dose recovered in urine from time 0 to 24 hours (Ae0-24)
Time frame: Day1-2
Cumulative percentage of dose recovered in urine from time 0 to 24 hours (fe0-24)
Time frame: Day1-2
Renal clearance in urine (CLr)
Time frame: Day1-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristi Mclendon, PhD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adamgammadex Sodium and 0.9% Sodium Chloride Injection in people with Healthy Volunteers, run by Amckaus PTY LTD. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs (time frame: 8 days max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.