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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502954
Recruitment Status : Terminated (Halted prematurely)
First Posted : April 19, 2018
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Affibody

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
Healthy Volunteers Biological: ABY-039 Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1, First-in-human, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Pharmacokinetic Study of ABY 039 in Healthy Subjects
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : March 20, 2020

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




Primary Outcome Measures :
  1. Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502954


Locations
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United Kingdom
PAREXEL Early Phase Unit
London, United Kingdom
Sponsors and Collaborators
Affibody
Parexel
Investigators
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Principal Investigator: Muna Albayaty, MD Parexel
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Responsible Party: Affibody
ClinicalTrials.gov Identifier: NCT03502954    
Other Study ID Numbers: ABY-039-001
2017-002918-32 ( EudraCT Number )
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No