ACTRN12624001003561
Not yet recruiting
Phase 1
A Phase 1a/b, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-628 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis D Infection
- Sponsor
- Bluejay Therapeutics, Inc.
- Enrollment
- 80
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Able and willing to provide written informed consent (signed and dated) and any
- •authorizations required by local law and can comply with all study requirements
- •2\. Male and female adults.
- •Phase 1a (Healthy Volunteers)
- •3\. 18 to 60 years of age, inclusive
- •4\. Body mass index (BMI) 18 to 35 kg/m2, inclusive
- •5\. In good health, in the judgment of the Investigator
Exclusion Criteria
- •1\. Pregnant or lactating females
- •2\. Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study.
- •3\. History or presence of central neurological or peripheral neuropathy disease from physical examination
- •4\. Family history of peripheral neuropathy
- •5\. History of or current migraine headaches
- •6\. Diabetes
- •7\. Treatment with a different investigational drug other than BJT\-628, a biological agent or device within 4 weeks or 5 half\-lives of Day 1, whichever is longer
- •8\. Clinically significant medical history of:
- •a) Cardiac diseases (e.g., myocardial infarctions, stroke, arrhythmia, heart failure, and coronary heart disease),
- •b) Autoimmune diseases (e.g., lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis, thyroiditis), or
Outcomes
Primary Outcomes
Not specified
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