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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Biological: ABY-039; Biological: Placebo

• Registration Number: NCT03502954
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-26
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-19
• Primary Completion: 2020-02-01
• Study Completion: 2020-03-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABY-039 IV	ABY-039	-
ABY-039 SC	ABY-039	-
Placebo IV	Placebo	-
Placebo SC	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PAREXEL Early Phase Unit; 🇬🇧 London, United Kingdom