This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetic of NP-011 in healthy volunteers.
NP-011 is a truncated form of human MFG-E8 recombinant protein. NP-011 placebo has an identical formulation to the NP-011 drug product, prepared without the active pharmaceutical ingredient. The study will be conducted in 2 parts: Single Ascending Dose (SAD): The participants will be randomized to receive NP-011 (n= 6 per cohort) or placebo (n= 2 per cohort) on Day 1. For all Part 1 cohorts, 2 sentinel participants will receive the first dose of IP (1 to receive NP-011, 1 to receive placebo) on Day 1. If dosing of the sentinel participants proceeds without clinically significant adverse events over 24 hours, the remaining participants in the cohort will be dosed at the discretion of the Principal Investigator (PI), according to the randomization schedule. There are total five cohorts in Part 1 Cohort 1A: NP-011 250 μg or placebo (6:2) Cohort 1B: NP-011 500 μg or placebo (6:2) Cohort 1C: NP-011 1000 μg or placebo (6:2) Cohort 1D: NP-011 2000 μg or placebo (6:2) Cohort 1E: NP-011 4000 μg or placebo (6:2) Multiple Ascending Dose (MAD): The part 2 progress after the completion of Day 8 assessments in Cohort 1E upon satisfactory review of all available safety data by the SMC. Participants will be enrolled into 3 sequential cohorts in Part 2. Dose levels for Part 2 cohorts may be revised by agreement with the SMC and based on emerging safety and PK data. Cohort 2A: NP-011 1000 μg or placebo (6:2) Cohort 2B: NP-011 2000 μg or placebo (6:2) Cohort 2C: NP-011 4000 μg or placebo (6:2) The participants will be randomized to receive the NP-011 (n= 6 per cohort) or placebo (n=2 per cohort) The safety and pharmacokinetic data will be reviewed by SMC in both the parts (SAD and MAD) prior to the decision to increase or decrease the dose level for the next cohort or expand the number of participants in a cohort (to a maximum of an additional 8 participants at a given dose level).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
The participants will receive assigned single dose of NP-011 after a minimum 8 hour fast on Day 1
The participants will receive assigned dose of NP-011 after a minimum 8 hour fast once daily for 7 days
The participants will receive single dose of NP-011 after a minimum 8 hour fast on Day 1 in Single Ascending Dose part and will receive once daily for 7 days after a minimum 8 hour fast in Multiple Ascending dose part of the study
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
The safety and tolerability of single and multiple doses of NP-011 through the incidence, nature and severity of adverse events
Adverse Events will be coded using the most current version of the MedDRA®
Time frame: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose
To characterize the plasma pharmacokinetics (PK) of NP-011 in healthy volunteers
Parameter: maximum concentration (Cmax)
Time frame: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose
To characterize the plasma pharmacokinetics (PK) of NP-011 in healthy volunteers
Parameter: time to maximum concentration (Tmax)
Time frame: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose
To characterize the plasma pharmacokinetics (PK) of NP-011 in healthy volunteers
Parameter: area under the concentration-time curve (AUC)
Time frame: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose
To characterize the immunogenicity of NP-011 in healthy volunteers by assessing the development of anti-drug-antibodies (ADA) through change from baseline in neutralizing antibody titers for NP-011 after single and multiple doses.
Time frame: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose
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