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 325568 Administered to Healthy Volunteers

Completed

• Conditions: 10018424; diabetes mellitus; disorder with hyperglycemia

• Registration Number: NL-OMON31095
• Lead Sponsor: ISIS Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

1. healthy subjects of either gender aged between 18-65 years
2. Females must be non-pregnant and non-lactating, and either
surgically sterile (hysterectomy, oophrectomy, or tubal ligation) or postmenopausal.
Males must be surgically sterile, abstinent or if engaged in sexual
relations of child-bearing potential, subject or partner must be using an acceptable
contraceptive method during the trial and for 9 weeks after the last dose of study
drug.
3. Give written informed consent to participate in study and availability for all study
requirements
4. Fasting plasma glucose <= the upper limit of the laboratory*s reference range
5. HbA1C <= ULN
6. BMI < 30 kg/m2

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tolerability of ISIS 325568<br /><br>PK of ISIS 325568<br /><br>Effects of ISIS 325568 (hepatic glucose production)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>