HealthyPhase 1NCT06181786
Study of NAV-240 in Healthy Volunteers
A Phase 1 study testing NAV-240 in people with Healthy, run by Navigator Medicines, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of NAV-240 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NAV-240
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 4 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant is 18 to 55 years of age, inclusive, at screening.
- The participant has a BMI of 18.5 to ≤ 32 kg/m^2 at screening.
- The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings not clinically significant at screening.
- Female participants of childbearing potential must use at least 1 form of highly effective methods of birth control from screening until at least 90 days after last study drug dose; OR be surgically sterile OR be postmenopausal. All female participants of childbearing potential must have a negative pregnancy test at screening and before the first dose of study drug. Female participants must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.
- Male participants must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (OR be surgically sterile; OR agree to practice abstinence during the study and for at least 90 days after study drug dosing).
- The participant agrees to comply with all protocol requirements.
- The participant is able to provide written informed consent.
Who cannot join
- 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:
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- Heart rate <40 or >100 beats per minute.
- PR interval >220 milliseconds (ms).
- QRS width >120 ms.
- QTcF >=450 ms (male) or >=470 ms (female).
- The participant has any of the following clinical laboratory results at screening, confirmed by repeat:
- WBCs, lymphocytes, or neutrophil counts outside site acceptable ranges per site SOPs.
- eGFR < 60 mL/min/1.73m^2 (the CKD-EPI formula)
- ALT or AST >2*ULN
- Total bilirubin >2*ULN
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Clinical Study to Evaluate Safety, Tolerability, and Pharmacokinetics of NAV-240 in Healthy Volunteers
The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of NAV-240 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- NAV-240, Placebo
- Keywords
- Pharmacokinetics, IMB-101, OX40L/TNF bispecific antibody, NAV-240
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAV-240Drug
Intravenous administration of NAV-240
PlaceboDrug
Intravenous administration of matching placebo for NAV-240
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses (SAD) of NAV-240 IV | Experimental | Single intravenous (IV) administration of ascending dose levels of NAV-240 Receives: Drug: NAV-240 |
| Single Doses of Placebo | Placebo comparator | Single intravenous (IV) administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the dose of study drug on Day 1 up to Day 71
Secondary outcomes (12)
Maximum Serum Concentration (Cmax) of NAV-240
Measured: From Day 1 prior to the first dose of study drug up to Day 71
Time to Maximum Serum Concentration (Tmax) of NAV-240
Measured: 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 336 hours post-dose (AUC0-336) of NAV-240
Measured: 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
Measured: 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
Measured: From Day 1 prior to the first dose of study drug up to Day 71
Serum Elimination Half-life (t1/2) of NAV-240
Measured: From Day 1 prior to the first dose of study drug up to Day 71
Terminal Elimination Rate Constant (λz) of NAV-240
Measured: From Day 1 prior to the first dose of study drug up to Day 71
Apparent Total Body Clearance (CL) of NAV-240
Measured: From Day 1 prior to the first dose of study drug up to Day 71
Apparent Volume of Distribution (Vz) of NAV-240
Measured: From Day 1 prior to the first dose of study drug up to Day 71
Trough Serum Concentration (Ctrough) of NAV-240
Measured: 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.
Measured: From the first dose of study drug up to Day 71
ADA Titers in Participants with Positive ADA
Measured: From the first dose of study drug up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start22 Nov 2023
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navigator Medicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IMBiologics Corp.
- Responsible party
- Sponsor
- Investigators
- Dana McClintock, MD, Study director, Navigator Medicines, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181786
- Sponsor's protocol ID
- IMB101-CR-01
- Status last verified
- Jun 2025
- First submitted
- 13 Dec 2023
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Clinical Study to Evaluate Safety, Tolerability, and Pharmacokinetics of NAV-240 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06181786
- Acronym / sponsor ID
- IMB101-CR-01
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, IMB-101, OX40L/TNF bispecific antibody, NAV-240
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Navigator Medicines, Inc.Industry (pharma, biotech, devices)
- Collaborators
- IMBiologics Corp.
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 26 Dec 2023 (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.
The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of NAV-240 in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses (SAD) of NAV-240 IV | Experimental | Drug: NAV-240Single intravenous (IV) administration of ascending dose levels of NAV-240 |
| Single Doses of Placebo | Placebo comparator | Drug: PlaceboSingle intravenous (IV) administration of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The participant is 18 to 55 years of age, inclusive, at screening.
- The participant has a BMI of 18.5 to ≤ 32 kg/m^2 at screening.
- The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings not clinically significant at screening.
- Female participants of childbearing potential must use at least 1 form of highly effective methods of birth control from screening until at least 90 days after last study drug dose; OR be surgically sterile OR be postmenopausal. All female participants of childbearing potential must have a negative pregnancy test at screening and before the first dose of study drug. Female participants must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.
- Male participants must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (OR be surgically sterile; OR agree to practice abstinence during the study and for at least 90 days after study drug dosing).
Key exclusion criteria (25 listed)
- 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:
- The participant has any of the following on 12-lead ECG prior to study drug dosing, confirmed by repeat:
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 |
|---|---|---|
| NAV-240Intravenous administration of NAV-240 | Drug | Single Ascending Doses (SAD) of NAV-240 IV |
| PlaceboIntravenous administration of matching placebo for NAV-240 | Drug | Single Doses of Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the dose of study drug on Day 1 up to Day 71
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.
12 secondary outcomes
Maximum Serum Concentration (Cmax) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Time to Maximum Serum Concentration (Tmax) of NAV-240
Time frame: 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 336 hours post-dose (AUC0-336) of NAV-240
Time frame: 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
Time frame: 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
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Serum Elimination Half-life (t1/2) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Terminal Elimination Rate Constant (λz) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Apparent Total Body Clearance (CL) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Apparent Volume of Distribution (Vz) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Trough Serum Concentration (Ctrough) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Incidence of Presence of Antidrug Antibodies (ADAs)
Time frame: From the first dose of study drug up to Day 71
ADA Titers in Participants with Positive ADA
Time frame: From the first dose of study drug up to Day 71
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 17 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Dana McClintock, MD study director
Navigator Medicines, Inc.
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 NAV-240 in people with Healthy, run by Navigator Medicines, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. 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 17 Jun 2025. 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 States. 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From the dose of study drug on Day 1 up to Day 71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2025.