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

Sponsor
Affibody (Industry)
Overall Status
Terminated
CT.gov ID
NCT03502954
Collaborator
Parexel (Industry)
66
1
4
24.7
2.7

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
  • Biological: ABY-039
  • Biological: Placebo
Phase 1

Study Design

Study Type:
Interventional
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 :
Feb 26, 2018
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Mar 20, 2020

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

  1. 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

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

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.
Responsible Party:
Affibody
ClinicalTrials.gov Identifier:
NCT03502954
Other Study ID Numbers:
  • ABY-039-001
  • 2017-002918-32
First Posted:
Apr 19, 2018
Last Update Posted:
Jun 17, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 17, 2020