Moderate to Severe AsthmaPhase 1NCT04307173
Study of Multiple Ascending Dose of KBL693 in Healthy Participants
A Phase 1 study testing KBL693 in people with Moderate to Severe Asthma, run by KoBioLabs at 1 site in Australia.
Trial summary
The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma.. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Asthma
- What is being tested?
- KBL693
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Aug 2020to 12 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (also referred to as participants) who can read and understand, and are willing to sign the informed consent form
- Willing and able to comply with clinic visits (including confinement to CTU) and study-related procedures
- Male or female healthy volunteers aged ≥18 and ≤65 years at Screening
- Body mass index (BMI) of ≥18.0 kg/m2 to ≤32 kg/m2 (both inclusive) at Screening
- 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.
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- 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
- 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
- Have regular bowel movements (e.g., once daily)
- 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).
- 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:
- Oral contraceptives ("the pill") for at least 1 month prior to Day 1, plus use of a condom
- Depot or injectable birth control or implantable contraception (e.g., Implanon) plus use of a condom
- Intrauterine device plus use of a condom
- Vasectomised male partner (performed at least 6 months prior) who has been documented to no longer produce sperm
- Women of non-child-bearing potential:
- Must have documented evidence of surgical sterilization at least 6 months prior to Screening visit e.g., tubal ligation, hysterectomy.
- Must be post-menopausal for at least 12 months prior to Screening, as documented by measurement of follicle stimulating hormone level (≥40 mIU/mL).
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
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- 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.
About this study
Official title: A Phase I Randomised Double-Blind Placebo-Controlled Study of Multiple Ascending Dose of KBL693 in Healthy Participants
The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma..
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single centre Phase I study.
Eighteen (18) subjects are planned to be randomised at 1 site across the 2 parts of the study as follows:
- Cohort 1: 680 mg/day
- Cohort 2: 6800 mg/day
- Conditions
- Moderate to Severe Asthma
- Being tested
- KBL693
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBL693Drug
Also called Placebo
Part 1: 680 mg/day of KBL693 or Placebo;
Route of Administration: Oral
KBL693Drug
Also called Placebo
Part 2: 6800 mg/day of KBL693 or Placebo;
Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 9 subjects for MAD 1 cohort. 6 subjects on KBL693, 3 subjects on placebo. Receives: Drug: KBL693 |
| Cohort 2 | Experimental | 9 subjects for MAD 2 cohort. 6 subjects on KBL693, 3 subjects on placebo. Receives: Drug: KBL693 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measure through Adverse Events/Serious Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Measurements at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
Measured by result of the Vital Sign- blood pressure
Measured: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate
Measured by result of the Vital Sign- heart rate
Measured: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature
Measured by result of the Vital Sign- axillary body temperature
Measured: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate
Measured by result of the Vital Sign- respiratory rate
Measured: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG
Measured by result of the ECG measurements and findings
Measured: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) 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
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Routine Stool Examination
Measured by result of the Bristol Stool Examination, Occult blood, Parasites
Measured: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results
Measured by clinically significant change from baseline clinical laboratory results
Measured: Measurement at Baseline till 28 days
Secondary outcomes (1)
Difference in the change from baseline in profile of faecal KBL693 between treatment arms
Measured by quantitative analysis method for understanding distribution and excretion of KBL693
Measured: Measurements 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.
- First posted13 Mar 2020
- Study start14 Aug 2020
- Primary completion30 Oct 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- KoBioLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Lara Hatchuel, Dr, Principal investigator, Linear Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307173
- Sponsor's protocol ID
- KBL-CURE-2020-01
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomised Double-Blind Placebo-Controlled Study of Multiple Ascending Dose of KBL693 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04307173
- Acronym / sponsor ID
- KBL-CURE-2020-01
- Conditions
- Moderate to Severe Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- KoBioLabsIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma..
Detailed description
This is a randomized, double-blind, placebo-controlled, single centre Phase I study.
Eighteen (18) subjects are planned to be randomised at 1 site across the 2 parts of the study as follows:
- Cohort 1: 680 mg/day
- Cohort 2: 6800 mg/day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: KBL6939 subjects for MAD 1 cohort. 6 subjects on KBL693, 3 subjects on placebo. |
| Cohort 2 | Experimental | Drug: KBL6939 subjects for MAD 2 cohort. 6 subjects on KBL693, 3 subjects on placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Healthy volunteers (also referred to as participants) who can read and understand, and are willing to sign the informed consent form
- Willing and able to comply with clinic visits (including confinement to CTU) and study-related procedures
- Male or female healthy volunteers aged ≥18 and ≤65 years at Screening
- Body mass index (BMI) of ≥18.0 kg/m2 to ≤32 kg/m2 (both inclusive) at Screening
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KBL693Also: PlaceboPart 1: 680 mg/day of KBL693 or Placebo; Route of Administration: Oral | Drug | Cohort 1 |
| KBL693Also: PlaceboPart 2: 6800 mg/day of KBL693 or Placebo; Route of Administration: Oral | Drug | Cohort 2 |
Primary outcome
Safety and tolerability measure through Adverse Events/Serious Adverse Events
Time frame: Measurements at Baseline till 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
Time frame: Measurement at Baseline till 28 days
Measured by result of the Vital Sign- blood pressure
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate
Time frame: Measurement at Baseline till 28 days
Measured by result of the Vital Sign- heart rate
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature
Time frame: Measurement at Baseline till 28 days
Measured by result of the Vital Sign- axillary body temperature
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate
Time frame: Measurement at Baseline till 28 days
Measured by result of the Vital Sign- respiratory rate
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG
Time frame: Measurement at Baseline till 28 days
Measured by result of the ECG measurements and findings
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam
Time frame: Measurement at Baseline till 28 days
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
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Routine Stool Examination
Time frame: Measurement at Baseline till 28 days
Measured by result of the Bristol Stool Examination, Occult blood, Parasites
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results
Time frame: Measurement at Baseline till 28 days
Measured by clinically significant change from baseline clinical laboratory results
1 secondary outcome
Difference in the change from baseline in profile of faecal KBL693 between treatment arms
Time frame: Measurements at Baseline till 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Hatchuel, Dr principal investigator
Linear Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KBL693 in people with Moderate to Severe Asthma, 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 19 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 21 Feb 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 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.