Status:
COMPLETED
A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects
Lead Sponsor:
7 Hills Pharma, LLC
Collaborating Sponsors:
Frontage Clinical Services, Inc.
Conditions:
Solid Tumor
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Detailed Description
This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multi...
Eligibility Criteria
Inclusion
- Healthy males between the ages of 18 and 45 years, inclusive
- Normal clinical chemistry, hepatic function, hematology, thyroid function
- Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
- Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
- Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0
Exclusion
- Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
- Current treatment or treatment within 30 days with another investigational medication
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04508179
Start Date
October 28 2020
End Date
October 25 2021
Last Update
November 2 2021
Active Locations (1)
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1
Frontage Clinical Services Inc.
Secaucus, New Jersey, United States, 07094