Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
ConditionType I Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorOp-T LLC
About this trial
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
Eligibility criteria
Qualifiers
1. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).
Disqualifiers
1. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.
Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.
Patients with recent immobilization or recent surgery.
Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome.
Trial design
Treatments tested in this trial
- OPT101
- OPT101 Placebo to Match (PTM)
Treatment groups
72 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov