Establishing a controlled human hookworm Infection Model

Malaghan Institute of Medical Research0 sites18 target enrollmentAugust 13, 2019

Conditionsautoimmune diseases allergic diseases Inflammatory and Immune System - Autoimmune diseases Alternative and Complementary Medicine - Other alternative and complementary medicine

Overview

Phase: 未知
Intervention: Not specified
Conditions: autoimmune diseases
Sponsor: Malaghan Institute of Medical Research
Enrollment: 18
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 13, 2019

End Date

July 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Malaghan Institute of Medical Research

Eligibility Criteria

Inclusion Criteria

•Participant has provided written informed consent and is willing to comply with all protocol scheduled visits, laboratory tests, and other trial procedures and in the opinion of the investigator has a good understanding of the protocol, the length of the study and the demands of the study.
•Participants will be male and non\-pregnant, non\-lactating females aged between 18 to 65 years.
•Participants must weigh more than 50kg with a BMI within the 18\.5 – 35kg/m2 range
•Participants must understand the procedures involved and agree to participate in the study by giving fully informed, written consent prior to any study assessment.
•Participants must be contactable and available for the duration of the clinical trial
•If female, has met either of criterion a” or b” below:
•(a) If of non\-childbearing potential, has met 1 of the following – Amenorrheic for at least 2 years, or has had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to screening, or has had a tubal ligation at least 8 weeks prior to screening.
•(b) If of childbearing potential, must be willing to use the acceptable methods of contraception
•In the opinion of the investigator is in good general health

Exclusion Criteria

•Current or history of helminth infection (other than E. vermicularis).
•Have any finding at screening that in the opinion of the investigator or medical monitor would compromise the safety of the participant or affect their ability to adhere to protocol scheduled visits, treatment plan, laboratory tests, and other trial procedures.
•Have participated in any other clinical trial and/or have received an investigational drug or device within 30 days of screening.
•History or current evidence of any of the following: compromised respiratory function (chronic obstructive pulmonary disease, respiratory depression, signs or symptoms of hypoxia at screening); thyroid pathology (unless stabilized and euthyroid for \>3 months at the time of screening); hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; evidence of clinically significant chronic cardiac, hepatic or renal disease; psychiatric illness (poorly controlled); seizure disorder or any other chronic health issues that in the opinion of the investigator would exclude the participant from the trial.
•Have one of the following laboratory abnormalities: ferritin \<20 ug/L, transferrin \<2\.04 g/L or Haemoglobin \<120 g/L for females or 130 g/L for males.
•History of severe asthma or other health conditions that may require future steroid use;
•History of substance abuse or current substance abuse that in the opinion of the investigator would exclude the participant from the trial.
•History of intolerance, allergy or hypersensitivity to the proposed anthelmintic – mebendazole.
•History of intolerance, allergy or hypersensitivity to the Betadine (iodine) solution used in preparation of Na that in the opinion of the investigator would exclude the participant from the trial.
•History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;