A Study of AST-008 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: AST-008

• Registration Number: NCT03086278
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Study Start: 2017-10-20
• Primary Completion: 2018-08-16
• Study Completion: 2018-08-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose	AST-008	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 1 month after the last dose of AST-008	To evaluate adverse events after a single subcutaneous dose of AST-008
Serious related adverse events	Up to 1 month after the last dose of AST-008	To evaluate SAEs after a single subcutaneous dose of AST-008

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration assessment	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
Pharmacodynamics	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
AUC assessment	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
QTc interval testing	Up to 1 month after the last dose of AST-008	To determine the effect of AST-008 on QTc interval
Dose finding	Up to 1 month after the last dose of AST-008	To recommend a dose and regimen for further development.

Trial Locations

Locations (1)

Richmond Pharmacology; 🇬🇧 London, United Kingdom