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A Study of AST-008 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086278
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Exicure, Inc.

Brief Summary:
AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: AST-008 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : August 16, 2018
Actual Study Completion Date : August 16, 2018

Arm Intervention/treatment
Experimental: Single Ascending Dose Drug: AST-008
AST-008 is a toll-like receptor 9 agonist.




Primary Outcome Measures :
  1. Serious related adverse events [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    To evaluate SAEs after a single subcutaneous dose of AST-008

  2. Adverse events [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    To evaluate adverse events after a single subcutaneous dose of AST-008


Secondary Outcome Measures :
  1. Dose finding [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    To recommend a dose and regimen for further development.

  2. Maximum plasma concentration assessment [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    Measurement of the maximum observed plasma concentration (Cmax) after single doses of AST-008

  3. AUC assessment [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    Measurement of the area under the curve (AUC) after single doses of AST-008

  4. Pharmacodynamics [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    Measurement of type 1 cytokine concentrations as a function of time after single doses of AST-008

  5. Pharmacodynamics [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    Measurement of changes in absolute number and and fraction of a panel of lymphocyte markers as a function of time after single doses of AST-008

  6. QTc interval testing [ Time Frame: Up to 1 month after the last dose of AST-008 ]
    To determine the effect of AST-008 on QTc interval



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria:

  1. Healthy male or female subjects aged ≥18 and ≤40 years of age at the time of first dosing.
  2. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
  3. Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
  4. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
  5. An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Main Exclusion Criteria:

  1. Current or recurrent disease (e.g., cardiovascular, haematological, neurological, endocrine, renal, liver, GI or other conditions) that could affect the action, absorption, or disposition of AST-008, or could affect clinical assessments or clinical laboratory evaluations.
  2. Any history of cancer.
  3. Any history (including significant and confirmed family history) of autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, autoimmune hepatitis, or thrombocytopenia.
  4. Has had an acute illness within two weeks prior to screening.
  5. Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  6. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study may influence the result of the study, or the subject's ability to participate in the study.
  7. Female subjects who are pregnant or breastfeeding.
  8. Subjects with abnormal findings of inguinal, axillary, or cervical lymph nodes at screening or Day -1.
  9. A positive human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen.
  10. Titres above reference ranges (according to local laboratory) for autoimmune antibodies: rheumatoid factor (RF), anti-nuclear antibodies (ANA), anti-neutrophil cytoplasmic antibodies (ANCA).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086278


Locations
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United Kingdom
Richmond Pharmacology
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Exicure, Inc.
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Responsible Party: Exicure, Inc.
ClinicalTrials.gov Identifier: NCT03086278    
Other Study ID Numbers: AST-008-101
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes