A Phase 1, Double Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 388626 Administered to Healthy Volunteers

Completed

• Conditions: Diabetes Mellitus; disorder with hyperglycemia; 10018424

• Registration Number: NL-OMON35464
• Lead Sponsor: ISIS Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

1. Healthy volunteers aged between 18 to 65 years
2. Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophrectomy or tubal ligation).
3. Give written informed consent to participate in the study and availability for all study requirements
4. Fasting plasma glucose <= the upper limit of the laboratory*s reference range (ULN)
5. HbA1c <= ULN
6. BMI < 30 kg/m2

Exclusion Criteria

1. Pregnant women, nursing mothers or women of childbearing potential
2. Presence of any of the following conditions:
a. Clinically significant abnormalities in medical history or physical examination
b. Clinically significant abnormalities in laboratory examination. (ALT > ULN, AST > ULN, bilirubin > ULN, creatinine > ULN, urine protein positive by dipstick, platelets < lower limit of normal and any other clinical significant laboratory findings)
c. Clinically significant abnormalities in coagulation parameters
d. Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
e. Active infection requiring antiviral or antimicrobial therapy
f. Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
g. Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
h. Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
3. History of alcohol or drug abuse
4. Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
5. Blood donation within three months of Screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified