A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-039
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ABY-039 IV
|
Biological: ABY-039
ABY-039
|
Experimental: ABY-039 SC
|
Biological: ABY-039
ABY-039
|
Placebo Comparator: Placebo IV
|
Biological: Placebo
Placebo
|
Placebo Comparator: Placebo SC
|
Biological: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections [Baseline up-to 11 weeks post-dose]
Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ABY-039
Eligibility Criteria
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
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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
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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
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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
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History of splenectomy, asthma (exception of resolved childhood asthma), or chronic obstructive pulmonary disease (COPD)
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | PAREXEL Early Phase Unit | London | United Kingdom |
Sponsors and Collaborators
- Affibody
- Parexel
Investigators
- Principal Investigator: Muna Albayaty, MD, Parexel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABY-039-001
- 2017-002918-32