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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04307173




Registration number
NCT04307173
Ethics application status
Date submitted
21/02/2020
Date registered
13/03/2020

Titles & IDs
Public title
Study of Multiple Ascending Dose of KBL693 in Healthy Participants
Scientific title
A Phase I Randomised Double-Blind Placebo-Controlled Study of Multiple Ascending Dose of KBL693 in Healthy Participants
Secondary ID [1] 0 0
KBL-CURE-2020-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KBL693
Treatment: Drugs - KBL693

Experimental: Cohort 1 - 9 subjects for MAD 1 cohort. 6 subjects on KBL693, 3 subjects on placebo.

Experimental: Cohort 2 - 9 subjects for MAD 2 cohort. 6 subjects on KBL693, 3 subjects on placebo.


Treatment: Drugs: KBL693
Part 1: 680 mg/day of KBL693 or Placebo;

Route of Administration: Oral

Treatment: Drugs: KBL693
Part 2: 6800 mg/day of KBL693 or Placebo;

Route of Administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability measure through Adverse Events/Serious Adverse Events
Timepoint [1] 0 0
Measurements at Baseline till 28 days
Primary outcome [2] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
Timepoint [2] 0 0
Measurement at Baseline till 28 days
Primary outcome [3] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate
Timepoint [3] 0 0
Measurement at Baseline till 28 days
Primary outcome [4] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature
Timepoint [4] 0 0
Measurement at Baseline till 28 days
Primary outcome [5] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate
Timepoint [5] 0 0
Measurement at Baseline till 28 days
Primary outcome [6] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG
Timepoint [6] 0 0
Measurement at Baseline till 28 days
Primary outcome [7] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam
Timepoint [7] 0 0
Measurement at Baseline till 28 days
Primary outcome [8] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Routine Stool Examination
Timepoint [8] 0 0
Measurement at Baseline till 28 days
Primary outcome [9] 0 0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results
Timepoint [9] 0 0
Measurement at Baseline till 28 days
Secondary outcome [1] 0 0
Difference in the change from baseline in profile of faecal KBL693 between treatment arms
Timepoint [1] 0 0
Measurements at Baseline till 28 days

Eligibility
Key inclusion criteria
1. Healthy volunteers (also referred to as participants) who can read and understand, and are willing to sign the informed consent form
2. Willing and able to comply with clinic visits (including confinement to CTU) and study-related procedures
3. Male or female healthy volunteers aged =18 and =65 years at Screening
4. Body mass index (BMI) of =18.0 kg/m2 to =32 kg/m2 (both inclusive) at Screening
5. Normal hemodynamic parameters: systolic blood pressure (BP) =90 mmHg and =140 mmHg; diastolic BP =50 mmHg and =90 mmHg; heart rate (HR) =40 bpm and =100 bpm at Screening and Day -1. Measurements may be repeated up to 3 times at the discretion of the investigator.

Please note: participants with out of range values, which are not clinically significant as per the principal investigator's (PI) discretion, will be allowed. The PI may delegate this responsibility to a suitably qualified and trained study team member.
6. The participant is, in the opinion of the PI (or delegate), generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other relevant laboratory tests
7. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at Screening and on Day -1. Out of normal ranges values may be accepted by the PI, if not clinically significant
8. Have regular bowel movements (e.g., once daily)
9. Male participants must agree to practise true abstinence; be surgically sterilised (performed at least 6 months prior); or agree to use of a condom if sexually active with a female partner of childbearing potential, from Screening through 90 days after the final dose of the investigational product (IP).
10. Women of child-bearing potential must agree to practise true abstinence or agree to use effective contraception from Screening through 90 days after the final dose of the IP.

Effective contraception includes:
1. Oral contraceptives ("the pill") for at least 1 month prior to Day 1, plus use of a condom
2. Depot or injectable birth control or implantable contraception (e.g., Implanon) plus use of a condom
3. Intrauterine device plus use of a condom
4. Vasectomised male partner (performed at least 6 months prior) who has been documented to no longer produce sperm
11. Women of non-child-bearing potential:

1. Must have documented evidence of surgical sterilization at least 6 months prior to Screening visit e.g., tubal ligation, hysterectomy.
2. Must be post-menopausal for at least 12 months prior to Screening, as documented by measurement of follicle stimulating hormone level (=40 mIU/mL).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Female participants who are pregnant or lactating
2. The participant's corrected QT interval (QTcF) (Fridericia's correction) is >450 msec (males), and >470 msec (females) at Screening or on Day -1. An out-of-range or abnormal ECG will be repeated at PI's discretion. In total, 3 ECGs should be recorded consecutively at Screening and on Day -1, and the PI (or delegate) must evaluate the triplicate ECG. If the participant's QTcF is >450 msec (males) or >470 msec (females) on at least 2 ECGs or have structural cardiac abnormalities, the participant must be excluded
3. The participant has taken prescription (including antibiotics) or non-prescription medication, herbal remedies, vitamins or minerals, any probiotic drinks and yeast supplements (e.g. Mutaflor®, Bioflor®) within 14 days prior to the first dose of study product unless in the opinion of the PI the medication will not compromise participant safety or interfere with study procedures or data validity. Participant may be rescreened after a washout period of 14 days. Please note use of oral contraceptives and paracetamol up to 2 g/day and/or nonsteroidal anti-inflammatory drugs for symptomatic relief of minor symptoms are allowed
4. Participant has functional GI disorders
5. Participant is a current smoker or has used nicotine containing products within 6 months prior to Screening visit
6. The participant has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the PI
7. The participant has taken any IP within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer
8. The participant has a history of significant hypersensitivity or anaphylaxis involving any drug (including ampicillin, clindamycin or imipenem), any constituent of the IP, food or other precipitating agent (e.g. bee sting). Please note participants with clinically stable mild allergic conditions such as hay fever and mild eczema may be enrolled at the discretion of the PI
9. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus antibody (anti-HCV)at Screening visit.
10. Positive screen for drugs of abuse and cotinine at Screening or on Day -1. Positive screen for alcohol on Day -1.
11. The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

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 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
14/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2020
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
KoBioLabs
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
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
Lara Hatchuel, Dr
Address 0 0
Linear Clinical Research
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/NCT04307173