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

September 6, 2021 updated by: KoBioLabs

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).

Study Overview

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)

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort SAD1
9 Subjects for SAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.

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

Route of Administration: Oral

Other Names:
  • Placebo

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

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD1:

460mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD2:

4,600mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo
EXPERIMENTAL: Cohort SAD2
9 Subjects for SAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.

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

Route of Administration: Oral

Other Names:
  • Placebo

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

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD1:

460mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD2:

4,600mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo
EXPERIMENTAL: Cohort MAD1
9 Subjects for MAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo

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

Route of Administration: Oral

Other Names:
  • Placebo

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

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD1:

460mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD2:

4,600mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo
EXPERIMENTAL: Cohort MAD2
9 Subjects for MAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo

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

Route of Administration: Oral

Other Names:
  • Placebo

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

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD1:

460mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo

Part B: 14 days

Cohort MAD2:

4,600mg/day of KBL697

Route of Administration: Oral

Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measurements at Baseline till 28 days
Safety and tolerability measure through Vital Sign
Time Frame: Measurement at Baseline till 28 days
Measured by result of the Vital Sign(blood pressure, heart rate, axillary body temperature, respiratory rate)
Measurement at Baseline till 28 days
Safety and tolerability measure through 12-lead ECG
Time Frame: Measurement at Baseline till 28 days
Measured by result of the ECG measurements and findings
Measurement at Baseline till 28 days
Safety and tolerability 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
Measurement at Baseline till 28 days
Safety and tolerability measure through Routine Stool Examination
Time Frame: Measurement at Baseline till 28 days
Measured by result of the Bristol Stool Examination, Occult blood, Parasites
Measurement at Baseline till 28 days
Safety and tolerability measure through Clinical laboratory results
Time Frame: Measurement at Baseline till 28 days
Measured by clinically significant change from baseline clinical laboratory results
Measurement at Baseline till 28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the change from baseline in profile of faecal KBL697 between treatment arms
Time Frame: Measurements at Baseline till 28 days
Measured by quantitative analysis method for understanding distribution and excretion of KBL697
Measurements at Baseline till 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ben Snyder, Dr, Nucleus Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 4, 2019

Primary Completion (ACTUAL)

December 23, 2019

Study Completion (ACTUAL)

January 7, 2020

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBL-CURE-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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