A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-039

Study Overview
=================
Brief Summary
-----------------
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-039 after single and multiple doses in healthy volunteers.

Official Title
-----------------
A Phase 1, First-in-human, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Pharmacokinetic Study of ABY 039 in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: ABY-039
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between 18 to 55 years of age agreeing to use highly effective methods of contraception Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, with a weight of at least 50 kg Non-smoker Subjects in good health Subjects with total immunoglobulin G (IgG) > 10 g/L at Screening Exclusion Criteria: Subjects who have donated blood in the 3 months prior to Screening, plasma in the 7 days prior to Screening or platelets in the 6 weeks prior to Screening Subjects who have received systemic corticosteroid treatment within 3 months of first dosing Subjects who have a history of significant drug allergy (e.g., anaphylaxis) or any clinically significant allergic condition (excluding non-active hay fever), as determined by the investigator Subjects who are still participating in another clinical study or received last investigational medical product (IMP) dose in a clinical study within the following time period prior to dosing: 3 months or 5 half-lives, whichever is longer History of splenectomy, asthma (exception of resolved childhood asthma), or chronic obstructive pulmonary disease (COPD) Positive for hepatitis A, hepatitis B, hepatitis C virus or antibodies to HIV-1 and/or HIV-2 or a positive QuantiFERON Gold Plus test at Screening Subjects who have received a live vaccination within 3 months prior to Screening or plan to have a live vaccination within 3 months after the last dose of study drug Subject unable or unwilling to comply with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABY-039 IV<br> | Biological: ABY-039<br>* ABY-039<br>|
| Experimental: ABY-039 SC<br> | Biological: ABY-039<br>* ABY-039<br>|
| Placebo Comparator: Placebo IV<br> | Biological: Placebo<br>* Placebo<br>|
| Placebo Comparator: Placebo SC<br> | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections | Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ABY-039 | Baseline up-to 11 weeks post-dose |