A Study of AST-008 in Healthy Subjects

NCT03086278 | Completed Phase 1 FDA Drug

• 1 other identifier: AST-008-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Dose finding

  Up to 1 month after the last dose of AST-008

• Maximum plasma concentration assessment

  Up to 1 month after the last dose of AST-008

• AUC assessment

  Up to 1 month after the last dose of AST-008

• Pharmacodynamics

  Up to 1 month after the last dose of AST-008

• Pharmacodynamics

  Up to 1 month after the last dose of AST-008

Study Arms (1)

Single Ascending Dose

EXPERIMENTAL

Drug: AST-008

Interventions

AST-008 DRUG

AST-008 is a toll-like receptor 9 agonist.

Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged ≥18 and ≤40 years of age at the time of first dosing.
• Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
• 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.
• 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.
• An understanding, ability, and willingness to fully comply with study procedures and restrictions.

You may not qualify if:

• 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.
• Any history of cancer.
• 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.
• Has had an acute illness within two weeks prior to screening.
• 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.
• 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.
• Female subjects who are pregnant or breastfeeding.
• Subjects with abnormal findings of inguinal, axillary, or cervical lymph nodes at screening or Day -1.
• A positive human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen.
• Titres above reference ranges (according to local laboratory) for autoimmune antibodies: rheumatoid factor (RF), anti-nuclear antibodies (ANA), anti-neutrophil cytoplasmic antibodies (ANCA).

Sponsors & Collaborators

• Exicure, Inc.: lead

Study Sites (1)

Richmond Pharmacology

London, SE1 1YR, United Kingdom

Location

Related Publications (1)

• Daniel WL, Lorch U, Mix S, Bexon AS. A first-in-human phase 1 study of cavrotolimod, a TLR9 agonist spherical nucleic acid, in healthy participants: Evidence of immune activation. Front Immunol. 2022 Dec 13;13:1073777. doi: 10.3389/fimmu.2022.1073777. eCollection 2022.

  PMID: 36582243 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 22, 2017
• Study Start: October 20, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

GB (1)