Clinical trial NCT03086278: A Study of AST-008 in Healthy Subjects
Official title: A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Exicure, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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.


Eligibility 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).

Primary outcomes:
measure: Serious related adverse events
timeFrame: Up to 1 month after the last dose of AST-008
measure: Adverse events
timeFrame: Up to 1 month after the last dose of AST-008
Secondary outcomes:
measure: Dose finding
timeFrame: Up to 1 month after the last dose of AST-008
measure: Maximum plasma concentration assessment
timeFrame: Up to 1 month after the last dose of AST-008
measure: AUC assessment
timeFrame: Up to 1 month after the last dose of AST-008
measure: Pharmacodynamics
timeFrame: Up to 1 month after the last dose of AST-008
measure: Pharmacodynamics
timeFrame: Up to 1 month after the last dose of AST-008
measure: QTc interval testing
timeFrame: Up to 1 month after the last dose of AST-008
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology
Study officials:
References: