Safety Study of ISIS 325568 in Healthy Volunteers
A Phase I, 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
2 other identifiers
interventional
60
1 country
1
Brief Summary
The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Aug 2007
Typical duration for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedAugust 19, 2008
August 1, 2008
8 months
August 21, 2007
August 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety and tolerability
30 days for single dose, 16 weeks for multi-dose
Secondary Outcomes (1)
Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups.
4 days for single dose, 16 weeks for multi-dose
Study Arms (8)
A
EXPERIMENTAL50 mg ISIS 325568 vs Placebo, s.c. injection
B
EXPERIMENTAL100 mg ISIS 325568 vs Placebo , s.c. injection
C
EXPERIMENTAL200 mg ISIS 325568 vs Placebo , s.c. injection
D
EXPERIMENTAL400 mg ISIS 325568 vs Placebo, s.c. injection
AA
EXPERIMENTAL50 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
BB
EXPERIMENTAL100 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
CC
EXPERIMENTAL200 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
DD
EXPERIMENTAL400 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
Interventions
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years
- Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. 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.
- Give written informed consent to participate in study and availability for all study requirements
- Fasting plasma glucose ≤ the upper limit of the laboratory's reference range (ULN)
- HbA1C ≤ ULN
- BMI \< 30 kg/m2
You may not qualify if:
- Clinically significant abnormalities in medical history or physical examination
- 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)
- History of clinically significant abnormalities in coagulation parameters
- Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- Active infection requiring antiviral or antimicrobial therapy
- Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year)
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
- History of alcohol or drug abuse
- Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
- Blood donation within three months of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Human Drug Research
Leiden, Netherlands
Related Publications (1)
Burel SA, Machemer T, Baker BF, Kwoh TJ, Paz S, Younis H, Henry SP. Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. Nucleic Acid Ther. 2022 Dec;32(6):457-472. doi: 10.1089/nat.2022.0033. Epub 2022 Aug 17.
PMID: 35976085DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Burggraaf, MD PhD
Centre for Human Drug Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 23, 2007
Study Start
August 1, 2007
Primary Completion
April 1, 2008
Study Completion
June 1, 2008
Last Updated
August 19, 2008
Record last verified: 2008-08