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| Name | Class |
|---|---|
| IMBiologics Corp. | INDUSTRY |
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The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of NAV-240 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Doses (SAD) of NAV-240 IV | Experimental | Single intravenous (IV) administration of ascending dose levels of NAV-240 |
|
| Single Doses of Placebo | Placebo Comparator | Single intravenous (IV) administration of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAV-240 | Drug | Intravenous administration of NAV-240 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs are defined as events that started after the first dose of study treatment or events that presented prior to the first dose of study drug but increased in severity after the first dose based on preferred term, including clinically relevant abnormal laboratory findings. SAEs are defined as any event that either results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | From the dose of study drug on Day 1 up to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 | |
| Time to Maximum Serum Concentration (Tmax) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
The participant has any significant acute or chronic medical illness that, in the opinion of the investigator, would impact the participant's ability to complete all study requirements or that might impact the assessment of study data; or the participant has had a clinically significant illness within 30 days prior to study drug dosing per investigator discretion.
The participant has a positive COVID-19 molecular diagnostic test result at screening or prior to study drug dosing; or the participant has known or suspected current sequelae from a prior episode of COVID-19.
The participant has had major surgery, as determined by the investigator, within 12 weeks prior to study drug dosing.
The participant has any of the following prior to study drug dosing:
• Systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg.
The participant has any of the following on 12-lead ECG prior to study drug dosing, confirmed by repeat:
The participant has any of the following clinical laboratory results at screening, confirmed by repeat:
The participant has a positive test result for HBsAg, anti-HBcAb, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
The participant has a history of TB, active TB, or a positive Quantiferon-TB Gold Plus (QFT-Plus) test at screening.
The participant has received any vaccine or used any prescription or over the-counter medications (except acetaminophen [up to 2 g per day]), including herbal or nutritional supplements, within 14 days prior to study drug dosing.
The participant has received biologic agents within the 3 months prior to study drug dosing, or 5 half-lives, whichever is greater. Participants with a prior history of anti-TNFα exposure will be excluded.
The participant is a smoker or has regularly used nicotine or nicotine-containing products within 3 months prior to study drug dosing.
History of drug abuse within 1 year prior to screening.
The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or prior to study drug dosing.
The participant has donated blood or blood products >500 mL within 30 days prior to study drug dosing.
The participant has a history of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes including allergy to drug or its excipients.
Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Dana McClintock, MD | Navigator Medicines, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health | Miami | Florida | 33136 | United States |
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| Placebo |
| Drug |
Intravenous administration of matching placebo for NAV-240 |
|
| Area Under the Serum Concentration-Time Curve From Time Zero to 336 hours post-dose (AUC0-336) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Area Under the Serum Concentration-Time Curve from Time Zero to the Concentration at a given Time Point (AUC0-t) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Serum Elimination Half-life (t1/2) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Terminal Elimination Rate Constant (λz) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Apparent Total Body Clearance (CL) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Apparent Volume of Distribution (Vz) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Trough Serum Concentration (Ctrough) of NAV-240 | From Day 1 prior to the first dose of study drug up to Day 71 |
| Incidence of Presence of Antidrug Antibodies (ADAs) | The formation of ADAs against NAV-240 as assessed in blood samples. Proportion of participants with positive or negative results for ADAs. | From the first dose of study drug up to Day 71 |
| ADA Titers in Participants with Positive ADA | From the first dose of study drug up to Day 71 |