A Phase 1 interventional study of K1-70 intramuscular or K1-70 intravenous in Graves' Disease, sponsored by AV7 Limited. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by AV7 Limited · Phase 1, Interventional, and Treatment
This study is the first time that K1-70 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when K1-70 is administered as an IM injection or as an IV infusion to subjects with Graves' disease.
Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium antagonists may be used to control some of the symptoms of hyperthyroidism.
K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo diagnostic and therapeutic tools for the management of patients with Graves' disease, patients with thyroid cancer and patients who would benefit from controlling receptor activity.
Graves' disease is one of the most common overt autoimmune disorders. Patients with Graves' disease have thyroid over activity and hyperthyroidism. Symptoms of hyperthyroidism include goitre, fatigue, heat intolerance, sweating, weight loss despite good appetite, shakiness, inappropriate anxiety, palpitations of the heart, shortness of breath, tetchiness and agitation, poor sleep, thirst, nausea and increased frequency of defaecation.
The rationale of this study is to obtain safety and tolerability data when K1-70 is administered as an intramuscular injection or as an IV infusion to subjects with Graves' disease.
This information, together with the pharmacokinetic data, will help establish the doses and dosage regimen suitable for repeat administration to patients.
This is an open-label study. The expected duration of each subject's participation in the study is approximately 18 weeks (including a screening period of up to 4 weeks).
150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 92 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →This is the only study on the registry with AV7 Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
The intervention is K1-70 intramuscular or K1-70 intravenous. This is a single, ascending, intramuscular or intravenous dose, sequential group study.
Drug: K1-70 intramuscular or K1-70 intravenous
Each subject will receive one dose of K1-70 by IM injection or one dose of K1-70 by IV infusion on the morning of Day 1.
Safety and tolerability will be measured using vital signs, ECG, blood samples for haematology, coagulation, clinical biochemistry and hormone panel, urinalysis, eye examinations, physical examinations and examination of injection or infusion site.
Safety and tolerability testing consists of vital signs, ECG, blood samples for haematology, coagulation, clinical biochemistry and hormone panel, urine samples for urinalysis, eye examinations, physical examinations and examination of injection or infusion site. All clinically significant results and the number of treatment related adverse events will be reported.
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
The terminal elimination rate constant will be calculated and reported
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
The terminal elimination half life will be calculated and reported
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
Time of the maximum observed plasma concentration will be calculated and reported
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
Maximum observed plasma concentration will be calculated and reported
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
Area under the plasma concentration time curve to the last quantified concentration will be calculated and reported
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
Area under the plasma concentration time curve from time zero to infinity will be calculated and reported
Time frame: Over a period of 18 weeks
The concentration of K1-70 drug in the blood will be measured over time.
Percentage of area under the plasma concentration time curve that is extrapolated will be calculated and reported
Time frame: Over a period of 18 weeks
The antidrug antibodies will be measured to evaluate the immunogenic potential of K1-70 in Graves' disease patients
The level of antidrug antibodies present in the patient serum will be measured over time and reported.
Time frame: Over a period of 18 weeks
The effect of a single IM dose or single IV dose of K1-70 on thyroid activity in subjects with Graves' will be measured over time
TSH levels will be measured and reported over time.
Time frame: Over a period of 18 weeks
The effect of a single IM dose or single IV dose of K1-70 on thyroid activity in subjects with Graves' will be measured over time
Free T3 levels will be measured and reported over time.
Time frame: Over a period of 18 weeks
The effect of a single IM dose or single IV dose of K1-70 on thyroid activity in subjects with Graves' will be measured over time
Free T4 levels will be measured and reported over time.
Time frame: Over a period of 18 weeks
Exploratory Objective: Thyroid hormones will be measured over time and their correlation to baseline TSH receptor autoantibody (TRAb) levels will be reported at different time points
TSH levels will be reported against baseline TRAb over time.
Time frame: Over a period of 18 weeks
Exploratory Objective: Thyroid hormones will be measured over time and their correlation to baseline TSH receptor autoantibody (TRAb) levels will be reported at different time points
Free T3 levels will be reported against baseline TRAb over time.
Time frame: Over a period of 18 weeks
Exploratory Objective: Thyroid hormones will be measured over time and their correlation to baseline TSH receptor autoantibody (TRAb) levels will be reported at different time points
Free T4 levels will be reported against baseline TRAb over time.
Time frame: Over a period of 18 weeks
Exploratory Objective: The potential effect of K1-70 on Graves' ophthalmopathy will be measured by eye examinations using the Clinical Activity Score (CAS) system.
All clinically significant results and the number of treatment related adverse events will be reported.
Time frame: Over a period of 18 weeks
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.