Safety Study on IdeS in Healthy Volounteers

Hansa Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: IdeS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01802697

11-HMedIdeS-01

2012-000969-21 (EudraCT Number)

Details and patient eligibility

About

This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).

Full description

A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).

Enrollment: 29 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to understand and sign informed consent
• BMI 19-30

Exclusion criteria

• Clinically significant disease

• Positive HIV, hepatistis B or C

  • Drug abuse

• Smoking

• Use of medication except paracetamol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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29 participants in 2 patient groups, including a placebo group

IdeS

Experimental group

Description:

Intravenous infusion

Treatment:

Drug: IdeS

PBS Buffer

Placebo Comparator group

Description:

Intravenous infusion

Treatment:

Drug: Placebo