Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE1RECRUITING

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.

Study details:

This Phase 1 study is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers. This is a randomized double-blind, placebo-controlled, ascending dose, multi-cohort trial. A total of 64 healthy volunteers are expected to be enrolled in 8 Cohorts.

The study will be conducted in two phases: A single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. In SAD, participants in Cohorts 1 - 2 will receive one dose of BWC0977 or placebo. In MAD, participants in cohorts 3 - 7 will receive multiple doses of BWC0977 or placebo for 7-10 consecutive days (as per the schedule).

In both parts, sequential cohorts will be exposed to increasing doses of BWC0977.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent
Body mass index (BMI): BMI ≥ 19.0 and ≤ 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
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.
Screening Tests: 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
Triplicate ECGs without clinically significant abnormalities, including a QTcF interval duration ≤450 msec (for males), and ≤470 msec (for females), obtained as an average from the triplicate screening ECGs after at least 5 minutes in a supine, quiet-rest position
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
Informed consent: Willing and able to provide written informed consent
Compliance: Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of events.
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.
Venous Access: Have suitable venous access for drug administration and blood sampling
Contraception Requirements (for those of reproductive potential): Contraception requirements will follow institutional policies.

Exclusion criteria

Pregnancy and Lactation: Women who are pregnant and/or lactating.
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 disease (including seizure disorders, psychiatric disorders), including any acute illness or surgery within the past 3 months, as determined by the Investigator to be clinically relevant.
History of any kidney disease or current or chronic history of impaired renal function as indicated by a calculated creatinine clearance (Cockcroft-Gault formula) <80 milliliter per minute (mL/min).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert syndrome or asymptomatic gallstones)
Clinically significant abnormal findings in serum chemistry, hematology, coagulation or urinalysis results obtained at screening or check-in (Day-1)
Alanine aminotransferase (ALT) more than (>)1 upper limit of normal (ULN) at screening or check-in (Day-1)
Aspartate aminotransferase (AST) > ULN at screening or check-in (Day-1)
Bilirubin >ULN at screening or check-in (Day-1)
Serum creatinine > ULN at screening or check-in (Day-1). The serum creatinine or any laboratory test may be repeated prior to confirming exclusion, at the PI's discretion.
Baseline QTcF of >450 msec (for males), and >470 msec (for females) at screening or check-in (Day-1)
History of photosensitivity to quinolones
History of known or suspected Clostridium difficile infection
Any condition that necessitated hospitalization within the 3 months prior to Day -1 or is likely to require so during the study
No systemic antibiotic use within 5 days before dosing.
Positive test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV antibodies), or human immunodeficiency virus antibody (antibodies to HIV-1, HIV-2) at screening.
Exclude participants receiving all prescription and OTC medications (except hormonal contraception and Paracetamol) 14 days or 5 half-lives, whichever is longer, prior to IP dosing.
Documented History of significant hypersensitivity reaction or anaphylaxis to any medication, as determined by the Medical Officer.
Smoker (including tobacco, e-cigarettes, or marijuana) or nicotine user within 1 month prior to dosing and have a positive test for cotinine at check in on Day -1.
Positive urine drug/alcohol breath testing at screening or check-in (Day -1), or history of substance abuse or alcohol abuse (defined as greater than 2 standard drinks on average each and every day, where one standard drink is defined as containing 10 g of alcohol and is equivalent to 1 can or stubby of mid-strength beer, 30 ml nip spirits, or 100 ml wine) within the previous 5 years.
Donation of blood within 30 days or plasma within 7 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrollment.
Previous participation in this study, i.e., who has already completed earlier cohorts or previous participation in another study within 5 half-lives (if known) of the agent, or 30 days, whichever is longer, of Day 1.
Consumption of red wine, Seville oranges, grapefruit, or grapefruit juice, pummelos, exotic citrus fruits, grapefruit hybrids, or fruit juices containing such products from 7 days prior to the first dose of study medication.
Employee or family member of an employee of the Sponsor, CRU, or clinical research organization at which the study will be conducted.
Unable to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be non-compliant with any study requirements.
Any other disease or condition that, in the opinion of the Investigator, would preclude the subject's participation in the study or place them at risk as a result of study participation.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1

Study ID

NCT07029932

Intervention or treatment

DRUG: BWC0977

DRUG: Placebo

Conditions

Infectious Diseases
Antimicrobial Drug Resistance

Condition: Infectious Diseases, Antimicrobial Drug Resistance
DRUG: BWC0977 and other drugs
Melbourne, Victoria, Australia
Sponsor: Bugworks Research Inc.

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Research sites nearby

Closest Location:

Nucleus Network

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Nucleus Network
Melbourne, Victoria, Australia

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Who is running the clinical trial?

BRI

Bugworks Research Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BWC0977 SAD Cohorts: Subjects will receive single doses of BWC0977 via IV infusion over 2 hours. Planned doses to be studied are: 750 mg and 1500 mg. MAD Cohorts: Subjects will receive multiple doses of BWC0977 via IV infusion over 30 minutes to 2 hours for 7-10 consecutive days (as per the schedule). Up to four dose groups will be studied. Planned doses and frequencies will be confirmed based on the safety, tolerability, and PK data of BWC0977 obtained in SAD and previous MAD Cohorts	Drug: BWC0977, Drug: Placebo
PLACEBO_COMPARATOR: Placebo The placebo used during this study is an active drug formulation without BWC0977. SAD Cohorts: Subjects will receive single infusions of placebo in 0.45% sodium chloride for injection over two hours. MAD Cohorts: Subjects will receive multiple infusions of placebo in 0.45% sodium chloride for injection over 30 minutes - 2 hours for 7-10 consecutive days (as per schedule). Frequency of infusions will be determined based on safety, tolerability, and PK data obtained for BWC0977 in SAD and previous MAD Cohorts.	Drug: BWC0977, Drug: Placebo

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: BWC0977

SAD Cohorts: Subjects will receive single doses of BWC0977 via IV infusion over 2 hours. Planned doses to be studied are: 750 mg and 1500 mg.
MAD Cohorts: Subjects will receive multiple doses of BWC0977 via IV infusion over 30 minutes to 2 hours for 7-10 consecutive days (as per the schedule). Up to four dose groups will be studied. Planned doses and frequencies will be confirmed based on the safety, tolerability, and PK data of BWC0977 obtained in SAD and previous MAD Cohorts

Drug: BWC0977, Drug: Placebo

PLACEBO_COMPARATOR: Placebo

The placebo used during this study is an active drug formulation without BWC0977.
SAD Cohorts: Subjects will receive single infusions of placebo in 0.45% sodium chloride for injection over two hours.
MAD Cohorts: Subjects will receive multiple infusions of placebo in 0.45% sodium chloride for injection over 30 minutes - 2 hours for 7-10 consecutive days (as per schedule). Frequency of infusions will be determined based on safety, tolerability, and PK data obtained for BWC0977 in SAD and previous MAD Cohorts.