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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04056130




Registration number
NCT04056130
Ethics application status
Date submitted
24/07/2019
Date registered
14/08/2019

Titles & IDs
Public title
A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects
Scientific title
A Phase I Randomized Double-blind Placebo-controlled Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects
Secondary ID [1] 0 0
KBL-CURE-2019-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis (AD) 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KBL697
Treatment: Drugs - KBL697
Treatment: Drugs - KBL697
Treatment: Drugs - KBL697

Experimental: Cohort SAD1 - 9 Subjects for SAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.

Experimental: Cohort SAD2 - 9 Subjects for SAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.

Experimental: Cohort MAD1 - 9 Subjects for MAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo

Experimental: Cohort MAD2 - 9 Subjects for MAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo


Treatment: Drugs: KBL697
Part A: 1 day 460mg/day of KBL697 or placebo

Route of Administration: Oral

Treatment: Drugs: KBL697
Part A: 1 day 4,600mg/day of KBL697

Route of Administration: Oral

Treatment: Drugs: KBL697
Part B: 14 days

Cohort MAD1:

460mg/day of KBL697

Route of Administration: Oral

Treatment: Drugs: KBL697
Part B: 14 days

Cohort MAD2:

4,600mg/day of KBL697

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 measure through Vital Sign
Timepoint [2] 0 0
Measurement at Baseline till 28 days
Primary outcome [3] 0 0
Safety and tolerability measure through 12-lead ECG
Timepoint [3] 0 0
Measurement at Baseline till 28 days
Primary outcome [4] 0 0
Safety and tolerability measure through Physical exam
Timepoint [4] 0 0
Measurement at Baseline till 28 days
Primary outcome [5] 0 0
Safety and tolerability measure through Routine Stool Examination
Timepoint [5] 0 0
Measurement at Baseline till 28 days
Primary outcome [6] 0 0
Safety and tolerability measure through Clinical laboratory results
Timepoint [6] 0 0
Measurement at Baseline till 28 days

Eligibility
Key inclusion criteria
1. Subjects able to read and understand, and willing to sign the informed consent form (ICF)
2. Male or female, aged 18 to 60 years (inclusive) at the time of Screening
3. Body mass index (BMI) of 18 kg/m2 to = 30 kg/m2 (both inclusive)
4. Willing and able to comply with clinic visits (including confinement to clinical trial unit) and study-related procedures
5. No history of allergic asthma
6. 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 Investigator, if not clinically significant.
7. Male subjects must abstain from heterosexual activities or agree to use a condom from screening through 90 days after the final dose of study drug. Women of child-bearing potential (WOCBP) must also abstain from heterosexual activities or agree to use effective contraception from screening through 90 days after the final dose of study drug.
8. Ability to remain in the study centre for up to a 3-day period for Part A of the study and up to a 15-day period for Part B of the study.
9. The subject is, in the opinion of the Investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other relevant laboratory tests.
10. Subject willing to allow storage of samples for genetic make-up in future studies.
Minimum age
18 Years
Maximum age
60 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
4/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2020
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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
Ben Snyder, Dr
Address 0 0
Nucleus Network
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/NCT04056130