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

NCT03502954 | Terminated Phase 1

• 2 other identifiers: ABY-039-0012017-002918-32
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections

  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

Study Arms (4)

ABY-039 IV

EXPERIMENTAL

Biological: ABY-039

ABY-039 SC

EXPERIMENTAL

Biological: ABY-039

Placebo IV

PLACEBO COMPARATOR

Biological: Placebo

Placebo SC

PLACEBO COMPARATOR

Biological: Placebo

Interventions

ABY-039 BIOLOGICAL

ABY-039

ABY-039 IV; ABY-039 SC

Placebo BIOLOGICAL

Placebo

Placebo IV; Placebo SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subjects in good health
• Subjects with total immunoglobulin G (IgG) \> 10 g/L at Screening

You may not qualify if:

• 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
• 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
• 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
• History of splenectomy, asthma (exception of resolved childhood asthma), or chronic obstructive pulmonary disease (COPD)
• 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
• 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

Sponsors & Collaborators

• Affibody: lead
• Parexel: collaborator

Study Sites (1)

PAREXEL Early Phase Unit

London, United Kingdom

Location

Study Officials

• Muna Albayaty, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 19, 2018
• Study Start: February 26, 2018
• Primary Completion: February 1, 2020
• Study Completion: March 20, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)