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

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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

30 participants in 1 patient group

Platform II, PASS, ARG 100
Other group
Treatment:
Other: Formulation buffers

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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