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

June 16, 2020 updated by: Affibody

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up-to 11 weeks post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affibody

Collaborators

Parexel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 26, 2018

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

March 20, 2020

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (ACTUAL)

April 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ABY-039-001
  • 2017-002918-32 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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