Overview

SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers

Status:
Recruiting
Trial end date:
2022-03-22
Target enrollment:
0
Participant gender:
All
Summary
The worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat. .
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Qpex Biopharma, Inc.
Collaborator:
Biomedical Advanced Research and Development Authority
Treatments:
Anti-Bacterial Agents
Polymyxins
Criteria
Inclusion Criteria:

1. Healthy adult males and/or females of non-child bearing potential, 18 to 60 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 a condom when engaging in any
sexual activity from Day -1 check-in to the clinic through 30 days following the last
administration of the study drug, and to not donate sperm during this same period of
time.. If engaging in sexual activity with a female partner of childbearing potential,
an additional method of birth control must be used.

Approved additional methods of birth control include:

1. Intra-uterine device (IUD) in place for at least 3 months prior to Day 1 through
30 days following the final dosing of the study drug.

2. Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days
following the final dosing of the study drug.

3. Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30
days following the final dosing of the study drug.

4. Surgical sterilization (vasectomy) at least 6 months prior to Day 1.

6. Females of non-childbearing potential must meet at least one of the following
criteria:

1. postmenopausal (defined as 12 months spontaneous amenorrhea) with a serum FSH
leve l≥ 40 mIU/mL.

2. have undergone one of the following sterilization procedures documented at least
6 months prior to Day 1:

- Bilateral tubal ligation

- Hysterectomy

- Hysterectomy with unilateral or bilateral oophorectomy

- Bilateral oophorectomy

3. Females who practice true abstinence or are in same sex relationships where there
is no possibility of conception.

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 screen or alcohol breath test 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 7 days prior to
dosing.

9. History of any hypersensitivity reaction or anaphylaxis to any medication, including
polymyxin 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.