None listed
Conditions
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of NAV 242 in healthy participants. Approximately 40 healthy adult volunteer participants, in Part A and Part B (up to 5 cohorts with 8 participants per cohort). Each part of the study will include a screening period of up to 6 weeks, a treatment period of 4 days (Part A), or 60 days (Part B) and a follow up period of 32 weeks. The approximate total study duration is 38 weeks for each participant in Part A, 46 weeks for each participant in Part B, 40 weeks.
Interventions
This is a Phase 1 study to evaluate the safety, tolerability, PK, PD, and immunogenicity of NAV-242 in healthy participants. The study is divided into two parts:
• Part A - a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult participants. Each participant enrolled in Part A will receive a single dose of the study drug via subcutaneous (SC) injection.
• Part B - a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in he
This is a Phase 1 study to evaluate the safety, tolerability, PK, PD, and immunogenicity of NAV-242 in healthy participants. The study is divided into two parts: • Part A - a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult participants. Each participant enrolled in Part A will receive a single dose of the study drug via subcutaneous (SC) injection. • Part B - a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy adult participants. Participants enrolled in Part B will receive up to 2 doses of the study drug either 4 weeks or 8 weeks apart, administered subcutaneously. Each part of the study will include a screening period, a treatment period, and a follow-up period. After signing the informed consent, participants will be screened over a period of up to 6 weeks prior to admission into the Phase 1 unit. During the screening period, medical history will be reviewed and tests/assessments will be done to determine if eligibility for the study is met. On Day -1, eligible participants will be admitted to the Phase 1 unit prior to administration of the study drug. For participants in Part A (SAD): Part A has 4 cohorts, corresponding to different dose levels of NAV-242 that will be administered via subcutaneous (SC) injection; Cohort A1 100mg (1mL), Cohort A2 300mg (3mL), Cohort A3 600 mg (6mL) and Cohort A4 800mg (8mL). The single dose will be administered on Day 1 in an inpatient setting. Participants will remain in the Phase 1 unit from Day -1 to Day 4, and will be discharged on Day 4 following 72-hour post-dose safety evaluation and PK sample collection. For participants in Part B (MAD): Part B has 2 cohorts, each with up to 2 different dose levels and intervals of NAV-242, administration via subcutaneous (SC) injection. Cohort B1 is a 4-week interval between a first dose of 400mg (4mL) and a second dose of 200mg (2mL); Cohort B2 is an 8-week interval between a first dose of 600mg (6mL) and second dose of 300mg (3mL). Both cohorts will have their first dose administered on Day 1 in an inpatient setting. Participants will remain in the Phase 1 unit from Day -1 to Day 4, and will be discharged on Day 4 following 72-hour post-dose safety evaluation and PK sample collection. The second doses of study drug will be administered on Day 29 (Cohort B1; 4-week interval) or Day 57 (Cohort B2 8-week interval). Participants will check-in to the Phase 1 unit the day before administration of the second dose and remain in the Phase 1 unit for72-hours post dosing for safety evaluation and PK sample collection (Days 28-32 for Cohort B1 and Days 56-60 for Cohort B2). Following each dose, all participants will return for outpatient follow-up visits and the End of study (EOS) visit: Part A, all cohorts: Outpatient follow-up visits on days 8, 15, 29, 57, 85, 113, 141 and EOS visit on Day 169 Cohort B1: Outpatient follow-up visits on days 8, 15, 36, 43, 57, 85, 113, 141, 169 and EOS visit on Day 197. Cohort B2: Outpatient follow-up visits on days 8, 15, 29, 64, 71, 85, 113, 141, 169, 197 and EOS visit on Day 225.
This is a Phase 1 study to evaluate the safety, tolerability, PK, PD, and immunogenicity of NAV-242 in healthy participants. The study is divided into two parts:
• Part A - a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult participants. Each participant enrolled in Part A will receive a single dose of the study drug via subcutaneous (SC) injection.
• Part B - a randomized, double-blind, placebo-controlled, multiple dose study in healthy adult part
This is a Phase 1 study to evaluate the safety, tolerability, PK, PD, and immunogenicity of NAV-242 in healthy participants. The study is divided into two parts: • Part A - a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult participants. Each participant enrolled in Part A will receive a single dose of the study drug via subcutaneous (SC) injection. • Part B - a randomized, double-blind, placebo-controlled, multiple dose study in healthy adult participants. Participants enrolled in Part B will receive up to 2 doses of the study drug 8 weeks apart, administered subcutaneously. Each part of the study will include a screening period, a treatment period, and a follow-up period. After signing the informed consent, participants will be screened over a period of up to 6 weeks prior to admission into the Phase 1 unit. During the screening period, medical history will be reviewed and tests/assessments will be done to determine if eligibility for the study is met. On Day -1, eligible participants will be admitted to the Phase 1 unit prior to administration of the study drug. For participants in Part A (SAD): Part A has 4 cohorts, corresponding to different dose levels of NAV-242 that will be administered via subcutaneous (SC) injection; Cohort A1 100mg (1mL), Cohort A2 300mg (3mL), Cohort A3 600 mg (6mL) and Cohort A4 800mg (8mL). The single dose will be administered on Day 1 in an inpatient setting. Participants will remain in the Phase 1 unit from Day -1 to Day 4, and will be discharged on Day 4 following 72-hour post-dose safety evaluation and PK sample collection. For participants in Part B: Part B has 1 cohort, each with a single dose level and interval of NAV-242, administration via subcutaneous (SC) injection. Part B is an 8-week interval between a first dose of 600mg (6mL) and second dose of 300mg (3mL). Participants will have their first dose administered on Day 1 in an inpatient setting. Participants will remain in the Phase 1 unit from Day -1 to Day 4, and will be discharged on Day 4 following 72-hour post-dose safety evaluation and PK sample collection. The second doses of study drug will be administered on Day 57. Participants will check-in to the Phase 1 unit the day before administration of the second dose and remain in the Phase 1 unit for 72-hours post dosing for safety evaluation and PK sample collection (Days 56-60). Following each dose, all participants will return for outpatient follow-up visits and the End of study (EOS) visit: Part A, all cohorts: Outpatient follow-up visits on days 8, 15, 29, 57, 85, 113, 141, 169, 197 and EOS visit on Day 225 Part B: Outpatient follow-up visits on days 8, 15, 29, 64, 71, 85, 113, 141, 169, 197, 225, 253 and EOS visit on Day 281.
Sponsors
Navigator Medicines
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
27 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 27- 65 years of age (inclusive) at the time of informed consent. 2. Medically healthy, in the opinion of the Investigator, with no clinically significant findings on medical history, physical examination, vital signs, or electrocardiograms (ECGs) at Screening, and/or before administration of the initial dose of study drug. 3. Participants must have clinical laboratory values within normal ranges as specified by the testing laboratory, unless deemed not clinically significant (NCS) by the Investigator. 4. Body mass index (BMI) 18 to 35 kg/m2 at Screening. 5. Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. 6. Willing and able to provide written informed consent.
Exclusion criteria
1. A relevant history of severe respiratory disease. 2. Any neurological, psychiatric, vascular, or system disorder that could also affect the evaluation of disease activity assessments. 3. History or evidence of an immunodeficiency disorder 4. Any other significant acute or chronic medical illness that might impact the participant’s ability to complete all study requirements, participant safety or data 5. History of alcoholism or drug abuse 6. A history and/or current presence of a clinically significant atopic allergy, hypersensitivity, or allergic reactions. 7. Known or suspected clinically relevant drug hypersensitivity to IP 8. A history of any infection requiring hospitalization, IV or oral antibiotics, or as otherwise judged clinically significant 9. A history of malignancy. 10. A history of New York Heart Association (NYHA) Class II, III or IV heart failure, active diabetes mellitus, active thyroid disease or cognitive impairment 11. A history of osteoporosis or previous treatment for osteoporosis, spontaneous/atraumatic fractures, pathological fractures, or any recent fractures (within 6months from Day 1). 12. Positive serology tests (HIV), syphilis, hepatitis B or hepatitis C virus antibody. 13. Positive anti-adalimumab antibody at Screening. 14. Clinically significant abnormality in bone turnover biomarkers at Screening, in the opinion of the Investigator. 15. A positive test result for drugs of abuse, cotinine, or alcohol at Screening and on Day -1. 16. Active TB or a history of TB, or a positive TB blood test at Screening. 17. Has received a live (attenuated) vaccine within 6 weeks prior to Day 1 or is expected to receive a live vaccine during the study and up to 90 days post last dose. Note, mRNA vaccines and influenza vaccines (inactivated) will be allowed during the study. 18. Received anti-TNF-a therapy in the past, confirmed by participant and Investigator. 19. Receipt of any investigational drug within 30 days prior to Screening or 5 half-lives, whichever is longer. 20. Females who are pregnant or breastfeeding. 21. Active cigarette smoker or other nicotine use
Outcome results
None listed