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A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers

RecruitingPhase 1Ages 18 Years - 55 YearsAllBugworks Research Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent 2. Body mass index (BMI): BMI โ‰ฅ 19.0 and โ‰ค 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) 3. Health Status: Medically healthy without significant history of any chronic diseases or conditions (such as cardiovascular, renal, hepatic, neurological, hematological, gastrointestinal, endocrine, or musculoskeletal disorders). Volunteers must have no clinically significant abnormalities in medical history, as determined by the Investigator. 4. Screening Tests: 1. No findings in Physical examination or vital signs (including temperature, heart rate, respiratory rate, and blood pressure) that the Investigator determines would interfere with interpretation of study results 2. Triplicate ECGs without clinically significant abnormalities, including a QTcF interval duration โ‰ค450 msec (for males), and โ‰ค470 msec (for females), obtained as an average from the triplicate screening ECGs after at least 5 minutes in a supine, quiet-rest position 3. For clinically significant abnormalities in the screening clinical laboratory tests, vital signs, and ECG assessments as determined by the Investigator, repeat testing could be performed at the Investigator's discretion 5. Informed consent: Willing and able to provide written informed consent 6. Compliance: Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of events. 7. Physical Activity Restrictions: Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from 4 days prior to admission in the clinical research unit (CRU) until completion of the study. 8. Venous Access: Have suitable venous access for drug administration and blood sampling 9. Contraception Requirements (for those of reproductive potential): Contraception requirements will follow institutional policies. Females: Must agree to use two forms of effective contraception-male partner using a condom plus 1 other highly effective method of birth control (e.g., Hormonal methods of contraception including oral contraceptives {includes Combined estrogen-progestin oral contraceptives (COCs) and progestogen-only contraceptives associated with inhibition of ovulation}, a vaginal ring, injectable and implantable hormonal contraceptives, indwelling intrauterine device, history of bilateral tubal ligation, sole vasectomized (bilateral vasectomy) partner with documented azoospermia 90 days after procedure) from signing the consent form until 33 days after last study drug administration, or agree to complete sexual abstinence for the duration of the study from screening and for 33 days after last study drug administration. Females of child-bearing potential must also agree not to donate ova or oocytes (i.e., human eggs) during the study, and for 33 days after completion of the study. For female participants, hormonal contraceptives should begin at least 1 month prior to screening to ensure the contraceptive is in full effect. To be considered of non-childbearing potential, a female must have either a hysterectomy, bilateral salpingo-oophorectomy (at least 3 months prior to screening), or menopause {last menstruation \>12 months in the absence of other biological causes and follicle-stimulating hormone levels in menopausal range (\>40mIU/mL)}, provision of written documentation is not required for female sterilization and oral confirmation is adequate. Female participants in same sex relationships do not need to utilize contraception. Males: If sexually active with a female partner of childbearing potential, must agree to use male condom plus 1 other highly effective method of birth control in their partner (e.g., Hormonal methods of contraception including oral contraceptives {includes Combined estrogen-progestin oral contraceptives (COCs) and progestogen-only contraceptives associated with inhibition of ovulation}, a vaginal ring, injectable and implantable hormonal contraceptives, indwelling intrauterine device, history of bilateral tubal ligation) from signing the consent form until 93 days after last study drug administration, or agree to complete sexual abstinence for the duration of the study from screening and for 93 days after last study drug administration. Hormonal contraceptives should be in use by female partner for at least 1 month prior to screening to ensure contraceptive is in full effect. To be considered surgically sterile, male participants must have had bilateral vasectomy at least 3 months before screening with appropriate documentation of the absence of sperm in the ejaculate 90 days after procedure. The use of condom by male partner will be required if bilateral vasectomy is the chosen highly effective method of birth control. Male participants must also agree not to donate sperms during the study and for 93 days after the last dose of the study drug. Male participants in same sex relationships or sexually active with female of non-childbearing potential (as defined above) do not need to utilize contraception. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level Exclusion Criteria: * 1\) Pregnancy and Lactation: Women who are pregnant and/or lactating. 2) Significant Medical History: History or presence of significant cardiovascular (including QT prolongation, clinically significant hypokalemia, or other proarrhythmic conditions), pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine (including glucose intolerance, diabetes mellitus), immunologic (including asthma or seasonal allergies \[that require intermittent use of steroids or other medication\]), musculoskeletal (including tendinopathy), dermatologic, or neurological di
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What it tests

  • BWC0977
  • Placebo
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Where

1 site
Nucleus Network
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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