This study is testing the safety, tolerability, pharmacokinetics (PK--the amount of study drug in the blood), pharmacodynamics (PD), how the study drug affects the body) and immunogenicity (how the study drug affects the immune system) of single and multiple doses and dose levels of an investigational drug called ALPN-101.
AIS-A01 is a phase 1, randomized, placebo-controlled, double-blinded study in healthy volunteers. It will be conducted at a single center and will enroll approximately 104 participants. The study will have 2 parts: * In Part A, participants will receive a single dose of study drug or placebo. Multiple dose levels of ALPN-101 will be evaluated. * In Part B, participants will receive 4 doses of ALPN-101 or placebo--1 dose each week for 4 weeks. Multiple dose levels of ALPN-101 will be evaluated. In each Part, safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
96
Nucleus Network- Centre for Clinical Studies
Melbourne, Victoria, Australia
Safety, as assessed by adverse events according to CTCAE v5.0
The rate of adverse events will be compared between the 2 treatment groups.
Time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4-8 weeks)
Pharmacokinetics of ALPN-101 as assessed by time of maximum ALPN-101 concentration.
Plasma levels of ALPN-101 will be serially evaluated following dosing of study drug, and the time of maximum plasma concentration (Tmax) will be identified.
Time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
Pharmacokinetics of ALPN-101 as assessed by the maximum concentration of ALPN-101.
Plasma levels of ALPN-101 will be serially evaluated following dosing of study drug, and the maximum plasma concentration (Cmax) will be calculated.
Time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
Pharmacokinetics of ALPN-101 as assessed by AUC on all subjects.
Plasma levels of ALPN-101 will be serially evaluated following dosing of study drug, and the area under the curve (AUC) will be calculated.
Time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
The incidence of ADA against ALPN-101 will be assessed and summarized.
The incidence of ADA against ALPN-101 will be assessed by the percentage of patients with a positive ADA result of all the treated patients.
Time frame: From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)
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