An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD

• Conditions: Cat allergic rhinistis and asthma; MedDRA version: 9.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2007-002715-11-DE
• Lead Sponsor: Circassia Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria
1. Male or female, aged 18-65 years.
2. A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1, see Appendix 3) on exposure to cats for at least 1 year.
3. Subjects who provide written informed consent.
4. Positive skin prick test to Leti cat allergen with a weal diameter at least 3mm larger than that produced by the negative control.
5. Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response for the mean of both arms.
6. The subject must be willing and able to comply with the study requirements as described in this protocol (and its amendments, if any).
7. If the subject is female and of childbearing potential she must practice an acceptable form of contraception (oral contraceptives, injectable or implantable methods, intra-uterine devices, sexual abstinence or a vasectomised partner), and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
1. Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled) (see Appendix 3).
2. A history of anaphylaxis to cat allergen.
3. Subjects with a cat specific IgE >100 kU/L.
4. Subjects with an FEV1 <80% of normal.
5. Subjects with an acute phase skin response to Leti cat allergen with a weal diameter > 30mm.
6. Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season.
7. Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever.
8. Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody.
9. Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria.
10. Subjects who do not respond to loratadine.
11. The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit.
12. Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
13. Subjects being treated with beta-blockers.
14. Subjects who have completed or are undergoing ongoing treatment with tranquillizers or psychoactive drugs.
15. Have symptoms of a clinically relevant illness, including urticaria factitia, in the Investigator’s opinion, within 6 weeks prior to Screening Visit.
16. Female subjects who are pregnant, lactating or planning a pregnancy during the study.
17. Have any clinically relevant abnormalities detected on physical examination.
18. 12-lead ECG or vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator.
19. Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator.
20. Significant history of alcohol or drug abuse.
21. History of hepatitis B, hepatitis C or HIV.
22. Have previously been randomised into this study or have received Cat-PAD (or a prototype thereof) previously.
23. Have a history of severe drug allergy or anaphylactic reaction to food.
24. Planned travel outside the study area for a substantial portion of the study period.
25. Have received treatment with an investigational drug within 6 months prior to study screening or have participated in a study with a new formulation of a marketed drug one month prior to study screening.
26. Any subject deemed by the Investigator to have questionable reliability in their ability to comply with the protocol and provide accurate information.
27. Are unable to communicate or to understand the requirements of the study, or any psychiatric disorder, which would impair communication between the subject and the Investigator thereby interfering with the informed cons

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified