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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, First-in-human, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Pharmacokinetic Study of ABY 039 in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03502954
• Other study ID #: ABY-039-001
• Secondary ID: 2017-002918-32
• Status: Terminated
• Phase: Phase 1
• Start date: February 26, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: June 2020
• Source: Affibody
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: March 20, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• ABY-039
ABY-039
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	PAREXEL Early Phase Unit	London

Sponsors (2)

Lead Sponsor	Collaborator
Affibody	Parexel

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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