P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV

• Status: Recruiting
• Trial end date: 2021-08-23
• Target enrollment: 0
• Participant gender: All

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 extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P. aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes, such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-beta-lactamase (VIM), and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Qpex Biopharma, Inc.
• Collaborator: Biomedical Advanced Research and Development Authority

Criteria

Inclusion Criteria:

1. Healthy adult males and/or females of non-child bearing potential, 18 to 55 years of age (inclusive).

2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).

3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination) as assessed by the PI.

4. Voluntarily consent to participate in the study.

5. 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.

6. 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 Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.

2. Positive urine drug/alcohol testing at screening or check-in (Day -1).

3. Positive testing for HIV, hepatitis B or C

4. History or presence of alcoholism or drug abuse within last 2 years

5. Use of more than 5 packs/week of tobacco/nicotine-containing product within last 6 months prior dosing.

6. Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to dosing.

7. Use of any over-the-counter (OTC) medication, including herbal products, probiotics and vitamins, within the 7 days prior to dosing.

8. Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to dosing.

9. History of any hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.

10. 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.

11. Females who are pregnant or lactating.

12. QTcF interval >450 msec for males and >470 msec for females, or history of prolonged QT syndrome at screening or check-in.

13. Calculated creatinine clearance less than 80 mL/min (Cockcroft-Gault method) at screening or check-in.

14. Subjects who have any clinically significant abnormalities on laboratory values: White blood cell count < 3,000/mm3, hemoglobin < 11g/dL or Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3.

15. Liver function abnormalities defined by an elevation in bilirubin, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) 1.5 x Upper Limit of Normal (ULN) of the normal range for subjects based on age and sex.