Status:
COMPLETED
P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV
Lead Sponsor:
Qpex Biopharma, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and...
Detailed Description
The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum beta-lactamase (...
Eligibility Criteria
Inclusion
- Healthy adult males and/or females of non-child bearing potential, 18 to 55 years of age (inclusive).
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
- Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms \[ECGs\], physical examination) as assessed by the PI.
- Voluntarily consent to participate in the study.
- If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from study check-in through completion of the end-of-study. Subjects must agree to use two approved methods of contraception for 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
- Females of non-childbearing potential with serum follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL are either postmenopausal (defined as 12 months spontaneous amenorrhea) or have undergone sterilization procedures at least 6 months prior to dosing.
Exclusion
- History or presence of significant (based on the PI assessment) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug/alcohol testing at screening or check-in (Day -1). A repeat test may be performed at the Investigator's discretion in circumstances where a positive result is suspected to be caused by consumption of non-illicit substances.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
- Use of more than an average of 5 packs/week of tobacco/nicotine-containing product within 6 months prior to Day 1. Subjects must agree to refrain from smoking for the duration of the study.
- Excessive intake of alcohol, defined as an average daily intake of greater than 2 standard drinks for women and 4 standard drinks for men, (1 bottle of beer (375mL) is equivalent to approximately 1.4 standard drinks, 1 glass of spirits (30mL) is equivalent to approximately 1 standard drink and 1 glass (150mL) of wine is equivalent to approximately 1.5 standard drinks).
- Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
- Use of any over-the-counter (OTC) medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of paracetamol is allowed for acute events at the discretion of the PI.
- Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to Day 1.
- Documented hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.
- Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Participation in another investigational clinical trial within 30 days prior to Day 1 or within 5 half-lives of the previous investigational drug, whichever is longer.
- Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.
- Any significant (based on the PI assessment) acute illness within 30 days prior to Day 1.
- QTcF interval \>450 msec for males and \>470 for females or history of prolonged QT syndrome at screening or check-in (Day -1).
- Calculated creatinine clearance less than 80 mL/min (Cockcroft- Gault method) at screening or check-in (Day -1).
- Subjects who have any clinically significant abnormalities on laboratory values at screening or check-in (Day -1), in particular:
- White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL.
- Absolute neutrophil count \< 1,200/mm3 or platelet count \< 120,000/mm3.
- Liver function abnormalities at screening or check-in (Day -1) (defined by an elevation in bilirubin, AST or ALT \> ULN of the normal range for subjects based on age and sex).
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study.
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04380207
Start Date
November 24 2020
End Date
August 31 2022
Last Update
October 10 2022
Active Locations (2)
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1
Altasciences
Cypress, California, United States, 90630
2
CMAX
Adelaide, South Australia, Australia