Healthy Volunteer StudyPhase 1NCT03086278
A Study of AST-008 in Healthy Subjects
A Phase 1 study testing AST-008 in people with Healthy Volunteer Study, run by Exicure, Inc. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AST-008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2017to 16 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- 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.
Main Exclusion Criteria:
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects
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
- Being tested
- AST-008
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-008Drug
AST-008 is a toll-like receptor 9 agonist.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Not described Receives: Drug: AST-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious related adverse events
To evaluate SAEs after a single subcutaneous dose of AST-008
Measured: 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
Measured: Up to 1 month after the last dose of AST-008
Secondary outcomes (6)
Dose finding
To recommend a dose and regimen for further development.
Measured: Up to 1 month after the last dose of AST-008
Maximum plasma concentration assessment
Measurement of the maximum observed plasma concentration (Cmax) after single doses of AST-008
Measured: Up to 1 month after the last dose of AST-008
AUC assessment
Measurement of the area under the curve (AUC) after single doses of AST-008
Measured: Up to 1 month after the last dose of AST-008
Pharmacodynamics
Measurement of type 1 cytokine concentrations as a function of time after single doses of AST-008
Measured: Up to 1 month after the last dose of AST-008
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
Measured: Up to 1 month after the last dose of AST-008
QTc interval testing
To determine the effect of AST-008 on QTc interval
Measured: Up to 1 month after the last dose of AST-008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start20 Oct 2017
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exicure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086278
- Sponsor's protocol ID
- AST-008-101
- Status last verified
- Sep 2018
- First submitted
- 10 Mar 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36582243
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03086278
- Acronym / sponsor ID
- AST-008-101
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Exicure, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.
Study design
- Primary purpose
- Screening
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: AST-008 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-008AST-008 is a toll-like receptor 9 agonist. | Drug | Single Ascending Dose |
Primary outcome
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
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
6 secondary outcomes
Dose finding
Time frame: Up to 1 month after the last dose of AST-008
Maximum plasma concentration assessment
Time frame: Up to 1 month after the last dose of AST-008
AUC assessment
Time frame: Up to 1 month after the last dose of AST-008
Pharmacodynamics
Time frame: Up to 1 month after the last dose of AST-008
Pharmacodynamics
Time frame: Up to 1 month after the last dose of AST-008
QTc interval testing
Time frame: Up to 1 month after the last dose of AST-008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Derived from this study: PubMed 36582243Daniel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AST-008 in people with Healthy Volunteer Study, run by Exicure, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious related adverse events (time frame: Up to 1 month after the last dose of AST-008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.