Study Evaluating Safety & Tolerability of Migaldendranib in Healthy Volunteers
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAshvattha Therapeutics, Inc.
About this trial
This is a Phase 1, open-label, multiple-dose study to evaluate the safety, tolerability, and PK of MGB after weekly subQ MGB administration in up to 36 healthy volunteers at 1 site in Australia.
Eligibility criteria
Qualifiers
Healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit
Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to any study-related procedures being completed
Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator
Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 year, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges
Disqualifiers
Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the participant at an unacceptable risk as a participant in this study
Evidence of systemic inflammation as measured by C-reactive protein above the upper limit of normal, as measured by the local lab
History of malignancy (other than successfully treated basal cell or squamous cell skin cancer)
History or presence of an abnormal electrocardiogram (ECG) that, in the opinion of the Investigator, is clinically significant
Trial design
Treatments tested in this trial
- MGB 200 mg
- MGB 400 mg
- MGB 600 mg
Treatment groups
36 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov