COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000834954.aspx

Dr Angela Molga

angela.molga@sa.gov.au

2020-08-24

Not recruiting

RCT

Randomized

Sequential assignment

Blind label

single-center

Prevention

To be eligible for this study, participants must meet all of the following criteria: 1. Healthy male and female volunteers aged >= 18 to <= 65 years at the time of informed consent. 2. In good health as determined by medical history and PE at Screening and Admission to the CRU. 3. Must have a minimum body weight of >=45 kg and <=100 kg and a BMI between 18 and 30 kg/m2, inclusive, at Screening. 4. Must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or their delegate. 5. Negative test for drugs of abuse at Screening and Admission to the CRU. 6. Negative test for alcohol use (breathalyzer) at Screening and Admission to the CRU. 7. Women of childbearing potential must use an acceptable, highly effective double barrier contraception from Screening until study completion, including the follow-up period. Double contraception is defined as a condom AND one other form of the following: a. Established hormonal contraception (oral contraceptive pill, long-acting implantable hormones, injectable hormones). b. A vaginal ring or an IUD). c. Documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner). Women not of childbearing potential must be postmenopausal for >=12 months at Screening. Postmenopausal status will be confirmed through testing of FSH levels >= 40 IU/mL at Screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participants who practice complete abstinence as part of their usual and preferred lifestyle will be eligible. Female participants who are in same sex relationships are not required to use contraception. WOCBP must have a negative pregnancy test at Screening and prior to administration of the initial dose of study drug and must be willing to have additional pregnancy tests as required throughout the study. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or, if engaged in sexual relations with a WOCBP, his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or the participant and his partner must be using an acceptable, highly effective double barrier contraceptive method from Screening until study completion, including the follow-up period. Acceptable methods of contraception include the use of condoms AND the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Participants with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle. 8. Male participants must not donate sperm for at least 90 days after the last dose of study drug. 9. Must have the ability and willingness to attend the necessary visits to the CRU. 10. Must be willing and able to provide written informed consent after the nature of the study has been expl

A participant who meets any of the following criteria must be excluded from the study: 1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period, until study completion. 2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant. Participants with history of the following will be excluded: irritable bowel syndrome, menorrhagia, fainting spells or dizzy spells or syncope, chronic abdominal or pelvic pain, hemoptysis, gastric ulcers, or anemia. Transient hemorrhage (e.g., infrequent epistaxis, normal menstrual bleeding, gingival bleeding, hemorrhoidal bleeding, etc.) would not preclude enrollment. 3. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. 4. Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug. 5. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Admission to the CRU. 6. Any acute illness within 30 days prior to Admission to the CRU. 7. History of severe allergic or anaphylactic reactions, determined at the discretion of the Investigator. 8. Known or suspected intolerance or hypersensitivity to the IP, closely related compounds, or any of the stated ingredients. 9. History of malignancy except for non-melanoma skin cancer excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening. 10. Abnormal ECG findings at Screening or Admission that are considered by the Investigator to be clinically significant. 11. History or presence of a condition associated with significant immunosuppression. 12. History of life-threatening infection (e.g., meningitis) within 5 years prior to Screening. 13. Infections requiring parenteral antibiotics within the 6 months prior to Screening. 14. Vaccination with a live-attenuated vaccine within the 4 weeks prior to Screening through to the EOS. 15. Exposure to any significantly immunosuppresive drug (including experimental therapies as part of a clinical trial) within the 4 months prior to Screening or five half-lives, whichever is longer. Topical steroids are allowed at the discretion of the Investigator. 16. Positive hepatitis panel (including HBsAg, HBcAb or anti-HCV), or a positive HIV antibody screen. 17. A BP value outside the specified range of 90 mm Hg to 160 mmHg (for SBP) and 50 mm Hg to 95 mmHg (for DBP, both inclusive) at Screening or Admission (can be repeated once at Screening at the Investigator’s discretion). 18. A history of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration). 19. Regular alcohol consumption defined as >14 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine) within 6 months of Screening. Participant is unwilling to abstain from alcohol beginning 48 hours prior to each visit and during the confinement period. 20. Regularly consume more than 8 cups (i.e., 2 L) daily of beverage containing caffeine and unable to abstain from caffeine- o

4

CytoAgents; Inc

18

65

Australia

Healthy volunteers

N/A

24

The frequency and severity of treatment-emergent adverse events (TEAEs); including clinically significant abnormal vital signs; ECGs; respiratory monitoring (including O2 saturation and spirometry); laboratory test results (including viral reactivation); cardiac telemetry results; and physical examination (PE) findings.[AE: Screening; Baseline; Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8 and Day 14.Vital signs: Vitals and orthostatic BP will be obtained at Screening; Baseline; predose and 1; 2; 3; 4; 6; and 8 hours post-morning dose on Day 1; predose and 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14.ECG: ECGs will be recorded at Screening; Baseline; pre-morning dose and at 1; 2; and 4 hours post-morning dose on Day 1; 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14. O2 Saturation: O2 saturation to be taken at Baseline; predose to dosing and at 2 hours (±30 minutes) post-morning dose on each day of dosing; prior to discharge on Day 8; and on Day 14.Spirometry: Baseline; Day 8 and Day 14.Biochemistry; coagulation; hematology: Blood samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14. Urinalysis (including microscopic examination and examination for casts): Urine samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14.Viral reactivation (EBV; HSV; VZV; CMV and HBV): Blood samples will be collected at Screening; prior to discharge on Day 8; and on Day 14.Cardiac telemetry monitoring: Continuous cardiac telemetry will be conducted for 48 hours; from the morning of Baseline (at least 24 hours prior to the first dose) to the morning of Day 2 (24 hours [+30 minutes] post first dose).Physical Examination: Complete PE during Screening and Symptom-directed PE at Baseline; Day 2; Day 5; Day 7; Day 8 and Day 14.];The frequency and severity of adverse events of special interest (AESIs); including clinically significant changes from baseline in coagulation parameters or platelets or persistent/recurrent symptomatic orthostatic hypotension.[AE: Screening; Baseline; Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8 and Day 14.Vital signs: Vitals and orthostatic BP will be obtained at Screening; Baseline; predose and 1; 2; 3; 4; 6; and 8 hours post-morning dose on Day 1; predose and 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14.Biochemistry; coagulation; hematology: Blood samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14. Urinalysis (including microscopic examination and examination for casts): Urine samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14.]

Phase 1

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