K1-70 – Safety Study in Subjects with Graves' Disease.
Research type
Research Study
Full title
K1-70 - A Phase I, Single Ascending Intramuscular Dose or Single Ascending Intravenous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Subjects with Graves’ Disease
IRAS ID
199697
Contact name
S D Singh
Contact email
Sponsor organisation
AV7 Ltd
Eudract number
2014-003815-12
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Patients with Graves’ disease have thyroid stimulating autoantibodies (proteins produced by the immune system) which stimulate the thyroid and cause thyroid over activity (hyperthyroidism). This study is being carried out to investigate K1-70, a monoclonal antibody, which is a potential new drug that blocks thyroid stimulating autoantibodies binding to the thyroid. This results in a reduction of the stimulation of the thyroid and a decrease in production of thyroid hormones. K1-70 is being developed for the diagnosis and treatment of people who have Graves’ disease, thyroid cancer, and patients who would benefit from controlling TSH receptor activity.
Each subject in the study will receive a single intra-muscular injection of K1-70 and this is the first time that the drug will be administered to humans.
The study will look at the potential side effects, tolerability, and pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of increasing dose levels of K1-70 on subjects with Graves’ disease.
The main aim is to find out the dose levels suitable for repeat administration to patients in the future. Up to 36 subjects will be included (at a single clinical trial site) in groups of up to 6. Each group will include at least 3 subjects.
Subjects will take part for a maximum of 14 weeks (which includes a screening period of up to 4 weeks). Subjects will attend for a screening visit, spend 4 days resident at the clinical trial unit and then visit the clinic on 8 subsequent outpatient visits. Blood samples and other tests (including ECGs, vital signs measurements, urine samples, eye examinations and general health reviews) will be carried out at the visits.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0149
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion