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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

MGB 200 mg
Drug
Participants receive weekly subcutaneous administration of MGB
MGB 400 mg
Drug
Participants receive an intermediate dose of MGB administered subcutaneously once weekly
MGB 600 mg
Drug
Participants receive the highest planned dose of MGB administered subcutaneously

Treatment groups

36 Participants

are divided into 3 treatment groups

Group A: MGB 200 mgExperimental treatment 1 intervention

Group B: MGB 400 mgExperimental treatment 1 intervention

Group C: MGB 600 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety and Tolerability of MGB

Safety will be assessed throughout the study by monitoring adverse events (AEs), including their incidence, severity, and relationship to study treatment. Additional safety assessments will include clinical laboratory evaluations (hematology, clinical chemistry, and urinalysis), physical examinations, and vital sign measurements, including pulse rate, blood pressure (BP), respiration rate, and tympanic temperature.

Time frame