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

• ClinicalTrials.gov Identifier: NCT04056130
• Recruitment Status: Recruiting
• First Posted: August 14, 2019
• Last Update Posted: September 19, 2019
• Sponsor: KoBioLabs
• Collaborator: Novotech (Australia) Pty Limited
• Information provided by (Responsible Party): KoBioLabs

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis (AD)	Drug: KBL697	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I Randomized Double-blind Placebo-controlled Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects
• Actual Study Start Date: September 16, 2019
• Estimated Primary Completion Date: December 23, 2019
• Estimated Study Completion Date: February 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort SAD1; 9 Subjects for SAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.	Drug: KBL697; Part A: 1 day 460mg/day of KBL697 or placebo Route of Administration: Oral; Other Name: Placebo
Experimental: Cohort SAD2; 9 Subjects for SAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo.	Drug: KBL697; Part A: 1 day 4,600mg/day of KBL697 Route of Administration: Oral; Other Name: Placebo
Experimental: Cohort MAD1; 9 Subjects for MAD 1 Cohort. 6 subjects on KBL697, 3 subjects on Placebo	Drug: KBL697; Part B: 14 days Cohort MAD1: 460mg/day of KBL697 Route of Administration: Oral; Other Name: Placebo
Experimental: Cohort MAD2; 9 Subjects for MAD 2 Cohort. 6 subjects on KBL697, 3 subjects on Placebo	Drug: KBL697; Part B: 14 days Cohort MAD2: 4,600mg/day of KBL697 Route of Administration: Oral; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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)
3. 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
4. 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
5. 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
6. 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

Other Outcome Measures:

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 subjects who are pregnant or lactating
2. The subject has either a history or presence of any clinically significant immunological disorder/disease (such as allergy, autoimmune diseases, etc.), cardiovascular, thromboembolic events, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (particularly diabetes or prediabetes), haematological, dermatological, venereal, neurological, chronic infectious or psychiatric disease or other major disorder.
3. History of cancer, including any form of skin cancer, which has not been in remission for at least 5 years prior to the first dose of study product.
4. The subject's corrected QT interval (QTcF) (Fridericia's correction) is >450 ms at screening and on Day -1. An out-of-range or abnormal ECG may be repeated. In total, 3 ECGs should be recorded consecutively, and the Investigator must evaluate the triplicate ECG. If the subject's QTcF is >450 ms on at least 2 ECGs, the subject must be excluded.
5. The subject has taken prescription (including antibiotics) or non-prescription medication, herbal remedies, vitamins or minerals.
6. The subject has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the Investigator.
7. The subject has taken any investigational products within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer.
8. The subject has a history of significant hypersensitivity or anaphylaxis involving any drug, food or other precipitating agent (e.g. bee sting).
9. The subject has any abnormal laboratory values that, in the opinion of the primary Investigator, are deemed clinically significant and would preclude participation in the study.
10. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at screening.
11. Positive screen for drugs of abuse or alcohol at screening or on Day -1. If result obtained during screening is positive, it can be repeated at Day -1.
12. The subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Contacts and Locations

Contacts

Contact: Sangwoo Lee; 2-888-9939 ext +82; swlee@kobiolabs.com

Locations

Australia, Victoria

Nucleus Network; Recruiting

Melbourne, Victoria, Australia, 3004

Contact: Ben Snyder, Dr 8593 9838 ext +61 3 b.snyder@nucleusnetwork.com.au

Sponsors and Collaborators

KoBioLabs

Novotech (Australia) Pty Limited

Investigators

• Principal Investigator: Ben Snyder, Dr; Nucleus Network

More Information

• Responsible Party: KoBioLabs
• ClinicalTrials.gov Identifier: NCT04056130 History of Changes
• Other Study ID Numbers: KBL-CURE-2019-01
• First Posted: August 14, 2019
• Last Update Posted: September 19, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases