Study of NAV-240 in Healthy Volunteers

NCT06181786 | Completed Phase 1 FDA Drug

• 1 other identifier: IMB101-CR-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Pharmacokinetics; IMB-101; OX40L/TNF bispecific antibody; NAV-240

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

• 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

Study Arms (2)

Single Ascending Doses (SAD) of NAV-240 IV

EXPERIMENTAL

Single intravenous (IV) administration of ascending dose levels of NAV-240

Drug: NAV-240

Single Doses of Placebo

PLACEBO COMPARATOR

Single intravenous (IV) administration of placebo

Drug: Placebo

Interventions

NAV-240 DRUG

Intravenous administration of NAV-240

Single Ascending Doses (SAD) of NAV-240 IV

Placebo DRUG

Intravenous administration of matching placebo for NAV-240

Single Doses of Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Navigator Medicines, Inc.: lead
• IMBiologics Corp.: collaborator

Study Sites (1)

Syneos Health

Miami, Florida, 33136, United States

Location

Study Officials

• Dana McClintock, MD

  Navigator Medicines, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: November 22, 2023
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)