The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- (Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
- (Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
- Physical examination findings within normal limits
- Body mass index (BMI) between 18 and 30, inclusive
Exclusion Criteria:
- Pregnancy and lactation
- Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
- Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
- History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
- History of drug abuse
- Participation in an investigational drug or device trial within the last 30 days prior to screening
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Healthy Volunteers
Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients.
|
In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were in SWFI. |
|
실험적: Allergic Asthma Participants
Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients.
|
In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were made in saline. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants by of Adverse Events Following a Skin Test Procedure
기간: Up to 7 days following skin testing
|
Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours. Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death. |
Up to 7 days following skin testing
|
|
Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)
기간: on the day of skin test
|
For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used.
Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control.
The skin prick test started with the lowest concentration.
If a positive skin reaction was observed, escalation to the next dilution was stopped.
|
on the day of skin test
|
|
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)
기간: on the day of skin test
|
For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used.
Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control.
The intradermal test started with the lowest concentration.
If a positive skin reaction was observed, escalation to the next dilution was stopped.
|
on the day of skin test
|
|
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)
기간: on the day of skin test
|
For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used.
Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control.
The intradermal test started with the lowest concentration.
If a positive skin reaction was observed, escalation to the next dilution was stopped.
|
on the day of skin test
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Dennis Wong, M.D., Genentech, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .