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Clinical Trial Details for A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects


KoBioLabs
NCT ID: NCT04056130
Last Updated: September 17, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 1
  • Gender: All
  • Age: 18 Years - 60 Years
  • Condition: Atopic Dermatitis (AD)
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: KoBioLabs
  • Location: Not Provided

Official Title

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

Purpose

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).

Eligibility

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

KoBioLabs

Novotech (Australia) Pty Limited

Investigators

Principal Investigator: Ben Snyder, Dr

Nucleus Network

Please refer to this study by its ClinicalTrials.gov identifier: NCT04056130

Location

Contacts

Nucleus Network

Melbourne, Victoria 3004

Australia