A Study of AST-008 in Healthy Subjects

Healthy Volunteer Study Clinical Trial

Official title:

A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086278
• Other study ID #: AST-008-101
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2017
• Est. completion date: August 16, 2018

Study information

• Verified date: September 2018
• Source: Exicure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 16, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• AST-008
AST-008 is a toll-like receptor 9 agonist.

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology	London

Sponsors (1)

Lead Sponsor	Collaborator
Exicure, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious related adverse events	To evaluate SAEs after a single subcutaneous dose of AST-008	Up to 1 month after the last dose of AST-008
Primary	Adverse events	To evaluate adverse events after a single subcutaneous dose of AST-008	Up to 1 month after the last dose of AST-008
Secondary	Dose finding	To recommend a dose and regimen for further development.	Up to 1 month after the last dose of AST-008
Secondary	Maximum plasma concentration assessment	Measurement of the maximum observed plasma concentration (Cmax) after single doses of AST-008	Up to 1 month after the last dose of AST-008
Secondary	AUC assessment	Measurement of the area under the curve (AUC) after single doses of AST-008	Up to 1 month after the last dose of AST-008
Secondary	Pharmacodynamics	Measurement of type 1 cytokine concentrations as a function of time after single doses of AST-008	Up to 1 month after the last dose of AST-008
Secondary	Pharmacodynamics	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	Up to 1 month after the last dose of AST-008
Secondary	QTc interval testing	To determine the effect of AST-008 on QTc interval	Up to 1 month after the last dose of AST-008