ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02101073

Enrollment

Registered

2014-04-01

Start date

2014-03-31

Completion date

2014-07-31

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The overall aims of the study are: * To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference. * To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061. * To further determine the safety and tolerability of ALX-0061. * To further evaluate the systemic (serum) immunogenicity of ALX-0061.

Interventions

BIOLOGICALALX-0061

single dose, intravenous

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: 1. Healthy volunteers. 2. Gender: male or female. 3. Age 18 to 55 years. 4. Body mass index (BMI): 18.0 ≥ BMI \< 30.0 kg/m2. Key

Exclusion criteria

1. Any active inflammatory condition, or autoimmune disorder such as lupus erythematosus, multiple sclerosis or rheumatoid arthritis (RA). 2. Any current or recent (within 4 weeks prior to dose) signs or symptoms of infection that requires parenteral antibiotic administration. 3. Symptomatic infection, or suspicion thereof in the last 1 week prior to dosing.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers	Day 1 to Day 32 +/- 2 days after dosing for low dose treatment arms, Day 1 to Day 46 +/-2 days after dosing for middle dose treatment arm, Day 1 to Day 53 +/- 2 days after dosing for high dose treatment arms

Secondary

Measure	Time frame	Description
Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6	During screening untill final visit (i.e. 60 +/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms)	—
Safety and tolerability: safety markers	From signing of informed consent until final visit (i.e. 60 +/- 2 days for the low dose and middle dose treatment arms and 83 +/- 2 days for the high dose treatment arms	* Adverse events and concomitant medication * Clinical laboratory * Vital signs * 12-lead ECG * Physical examination * Local reactions
Immunogenicity: concentration of Anti-Drug Antibodies (ADA) in serum	From screening until final visit (i.e. 60+/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026