AzTrials
AzTrials

Atopic Dermatitis (AD)Phase 1NCT04056130

A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects

A Phase 1 study testing KBL697 in people with Atopic Dermatitis (AD), run by KoBioLabs at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is designed to investigate the safety and tolerability of KBL697 in healthy volunteers. KBL697 has been developed as a potential new treatment for atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
KBL697
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteAustralia
Study dates
4 Oct 2019to 7 Jan 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects able to read and understand, and willing to sign the informed consent form (ICF)
  • Male or female, aged 18 to 60 years (inclusive) at the time of Screening
  • Body mass index (BMI) of 18 kg/m2 to ≤ 30 kg/m2 (both inclusive)
  • Willing and able to comply with clinic visits (including confinement to clinical trial unit) and study-related procedures
  • No history of allergic asthma
  • 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.
Show all 10Show fewer
  • 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.
  • 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.
  • 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.
  • Subject willing to allow storage of samples for genetic make-up in future studies.

Who cannot join

  • Female participants who are pregnant or lactating
  • 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
  • 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
  • Participant has functional GI disorders
  • Participant is a current smoker or has used nicotine containing products within 6 months prior to Screening visit
  • The participant has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the PI
Show all 11Show fewer
  • The participant has taken any IP within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer
  • 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
  • Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus antibody (anti-HCV)at Screening visit.
  • Positive screen for drugs of abuse and cotinine at Screening or on Day -1. Positive screen for alcohol on Day -1.
  • The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Phase I Randomized Double-blind Placebo-controlled Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects

The study is designed to investigate the safety and tolerability of KBL697 in healthy volunteers. KBL697 has been developed as a potential new treatment for atopic dermatitis (AD).

Read the detailed description

This is a randomized double-blind, placebo-controlled, single centre Phase I study.

Thirty-six (36) subjects are planned to be randomised at

1 site across the 2 parts of the study as follows:

  • Part A (Single Ascending Dose (SAD) in healthy subjects)
  • Part B (Multiple Ascending Doses (MAD) in healthy subjects)
Being tested
KBL697
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KBL697Drug

    Also called Placebo

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

    Route of Administration: Oral

  • KBL697Drug

    Also called Placebo

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

    Route of Administration: Oral

  • KBL697Drug

    Also called Placebo

    Part B: 14 days

    Cohort MAD1:

    460mg/day of KBL697

    Route of Administration: Oral

  • KBL697Drug

    Also called Placebo

    Part B: 14 days

    Cohort MAD2:

    4,600mg/day of KBL697

    Route of Administration: Oral

Study groups in NCT04056130
Study groupRoleWhat they receive
Cohort SAD1Experimental9 Subjects for SAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.
Receives: Drug: KBL697
Cohort SAD2Experimental9 Subjects for SAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.
Receives: Drug: KBL697
Cohort MAD1Experimental9 Subjects for MAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo
Receives: Drug: KBL697
Cohort MAD2Experimental9 Subjects for MAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo
Receives: Drug: KBL697

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability measure through Adverse Events/Serious Adverse Events

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Measurements at Baseline till 28 days

  2. Safety and tolerability measure through Vital Sign

    Measured by result of the Vital Sign(blood pressure, heart rate, axillary body temperature, respiratory rate)

    Measured: Measurement at Baseline till 28 days

  3. Safety and tolerability measure through 12-lead ECG

    Measured by result of the ECG measurements and findings

    Measured: Measurement at Baseline till 28 days

  4. Safety and tolerability measure through Physical exam

    Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic

    Measured: Measurement at Baseline till 28 days

  5. Safety and tolerability measure through Routine Stool Examination

    Measured by result of the Bristol Stool Examination, Occult blood, Parasites

    Measured: Measurement at Baseline till 28 days

  6. Safety and tolerability measure through Clinical laboratory results

    Measured by clinically significant change from baseline clinical laboratory results

    Measured: Measurement at Baseline till 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2019
  2. Study start4 Oct 2019
  3. Primary completion23 Dec 2019
  4. Study completion7 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04056130
Sponsor's protocol ID
KBL-CURE-2019-01
Status last verified
Sep 2021
First submitted
24 Jul 2019
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KBL697 in people with Atopic Dermatitis (AD), run by KoBioLabs at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability measure through Adverse Events/Serious Adverse Events (time frame: Measurements at Baseline till 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04056130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in