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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04380207




Registration number
NCT04380207
Ethics application status
Date submitted
21/04/2020
Date registered
8/05/2020
Date last updated
30/09/2020

Titles & IDs
Public title
P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of Intravenous (IV) QPX7728 Alone and in Combination With QPX2014 in Healthy Adult Subjects
Secondary ID [1] 0 0
Qpex-200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QPX7728
Treatment: Drugs - Placebo
Treatment: Drugs - QPX2014

Experimental: QPX7728 - antibiotic

Placebo Comparator: Placebo - Matched placebo

Experimental: QPX2014 - antibiotic


Treatment: Drugs: QPX7728
antibiotic

Treatment: Drugs: Placebo
Placebo comparator

Treatment: Drugs: QPX2014
antibiotic

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment -Emergent Adverse events (AEs) by subject and by cohort (single, multiple and combination dose) - Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment
Timepoint [1] 0 0
up to 2 weeks
Primary outcome [2] 0 0
Number of patients with changes from baseline in safety parameters (single, multiple and combination dose) - Number of patients with changes in safety parameters before and after dosing by subject and treatment arm
Timepoint [2] 0 0
up to 2 weeks
Primary outcome [3] 0 0
Peak plasma Concentration measurements by subject and by cohort (Cmax) (single, multiple and combination dose) - Comparison will be performed between the cohorts for Cmax. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Timepoint [3] 0 0
Study Days 1 to 4, 12 and 14
Primary outcome [4] 0 0
Area under the plasma concentration versus time curve (AUC) between cohorts (single, multiple and combination dose) - Comparison will be performed between the cohorts for AUC. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Timepoint [4] 0 0
Study Days 1 to 4, 12 and 14
Primary outcome [5] 0 0
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort (single, multiple and combination dose) - Urine PK parameters such as amount excreted will be calculated from urinary excretion data
Timepoint [5] 0 0
up to 7 days of dosing
Primary outcome [6] 0 0
Urine PK % dose excreted by subject and by cohort (single, multiple and combination dose) - Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data
Timepoint [6] 0 0
up to 7 days of dosing

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Qpex Biopharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Biomedical Advanced Research and Development Authority
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/show/NCT04380207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffery S Loutit, MBChB
Address 0 0
Qpex Biopharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elizabeth E Morgan
Address 0 0
Country 0 0
Phone 0 0
858-500-8388
Fax 0 0
Email 0 0
lmorgan@qpexbio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04380207