Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

Ablynx

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Formulation buffers

Study type: Interventional

Funder types: Industry

Identifiers

NCT01401764

B2271022

2011-000419-15

Details and patient eligibility

About

The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
• Body mass index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion criteria

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 1 patient group

Platform II, PASS, ARG 100

Other group

Treatment:

Other: Formulation buffers