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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04380207
Ethics application status
Date submitted
21/04/2020
Date registered
8/05/2020

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)
Timepoint [1] 0 0
up to 21 days
Primary outcome [2] 0 0
Number of patients with changes from baseline in safety parameters (single, multiple and combination dose)
Timepoint [2] 0 0
up to 21 days
Primary outcome [3] 0 0
Peak plasma Concentration measurements by subject and by cohort (Cmax) (single, multiple and combination dose)
Timepoint [3] 0 0
up to 21 days
Primary outcome [4] 0 0
Area under the plasma concentration versus time curve (AUC) between cohorts (single, multiple and combination dose)
Timepoint [4] 0 0
up to 21 days
Primary outcome [5] 0 0
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort (single, multiple and combination dose)
Timepoint [5] 0 0
up to 21 days
Primary outcome [6] 0 0
Urine PK % dose excreted by subject and by cohort (single, multiple and combination dose)
Timepoint [6] 0 0
up to 21 days

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
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of significant (based on the PI assessment) 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). 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.
3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
5. 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.
6. 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).
7. Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
8. 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.
9. Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to Day 1.
10. Documented hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.
11. Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
12. Plasma donation within 7 days prior to Day 1.
13. 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.
14. Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.
15. Any significant (based on the PI assessment) acute illness within 30 days prior to Day 1.
16. QTcF interval >450 msec for males and >470 for females or history of prolonged QT syndrome at screening or check-in (Day -1).
17. Calculated creatinine clearance less than 80 mL/min (Cockcroft- Gault method) at screening or check-in (Day -1).
18. Subjects who have any clinically significant abnormalities on laboratory values at screening or check-in (Day -1), in particular:

1. White blood cell count < 3,000/mm3, hemoglobin < 11g/dL.
2. Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3.
19. 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).
20. Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2022
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04380207