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

Affibody

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: ABY-039; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03502954

2017-002918-32 (EudraCT Number)

ABY-039-001

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 4 patient groups, including a placebo group

ABY-039 IV

Experimental group

Treatment:

Biological: ABY-039

ABY-039 SC

Experimental group

Treatment:

Biological: ABY-039

Placebo IV

Placebo Comparator group

Treatment:

Biological: Placebo

Placebo SC

Placebo Comparator group

Treatment:

Biological: Placebo