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

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

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.

Inclusion Criteria:

1. Healthy male and female subjects between 18 to 55 years of age agreeing to use highly effective methods of contraception
2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, with a weight of at least 50 kg
3. Non-smoker
4. Subjects in good health
5. Subjects with total immunoglobulin G (IgG) > 10 g/L at Screening

Exclusion Criteria:

1. 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
2. Subjects who have received systemic corticosteroid treatment within 3 months of first dosing
3. 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
4. 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
5. History of splenectomy, asthma (exception of resolved childhood asthma), or chronic obstructive pulmonary disease (COPD)
6. 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
7. 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
8. Subject unable or unwilling to comply with the protocol