Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males

NCT00599001 | Completed Phase 1

• 1 other identifier: DV3-HNV-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.

Conditions

Healthy

Keywords

healthy volunteer; research subjects; Immunostimulatory sequence (ISS); phase 1

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with and the amplitude and timing of adverse events, proportion of subjects with and the grade and timing of abnormal lab values, and proportion of subjects with and timing of changes in physical exam findings and vital signs

  Up to 7 days after dosing

Secondary Outcomes (3)

• Pharmacokinetic parameters

  Up to 24 hours after dosing

• Levels of serum cytokines

  Up to 7 days after dosing

• Levels of blood biomarkers (interferon-alpha inducible genes)

  Up to 7 days after dosing

Study Arms (2)

Escalating Dose of SD-101

EXPERIMENTAL

Drug: SD-101

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SD-101 DRUG

Single subcutaneous escalating dose

Escalating Dose of SD-101

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed, written, informed consent must be obtained from the subjects before any study-specific procedures are performed.
• Subject must be male and 18 years of age or older.
• Subject must be willing to submit to a urine drug screen and agree to abstain from alcohol, caffeine, and tobacco during the required stay in the Phase I Unit.
• Subject must be willing to abide by the rules of the Phase 1 Unit.
• Subjects whose sexual partners are of childbearing potential must agree to use an effective method of birth control (i.e., chemical contraceptives, barrier plus spermicide, intrauterine device) during the treatment phase and for 14 days post treatment.
• Must be negative for Hepatitis B and C and human immunodeficiency virus (HIV).

You may not qualify if:

• Females.
• Clinically significant active, acute, or chronic illness.
• History of coagulation or bleeding disorders.
• Clinically significant chronic or recent (within 21 days of dosing) acute gastrointestinal disorder with nausea, vomiting or diarrhea as a major symptom.
• Received any vaccine within 3 weeks of study entry or plans to be vaccinated within 6 weeks after study injection.
• History of significant cardiovascular or cerebrovascular disease.
• History of evaluation for autoimmune disease including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), scleroderma or thyroiditis.
• Significant psychiatric illness that could potentially interfere with the assessments during this study.
• Subjects who have had prior surgery or a major infection within 6 months of dosing.
• History of medications within 7 days of dosing, except vitamins and/or minerals.
• History of Gilbert's disease.

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead

Study Sites (1)

Healthcare Discoveries, Inc.

San Antonio, Texas, 78209, United States

Location

Related Links

• Sponsor Website

Study Officials

• Dennis Ruff, MD

  Healthcare Discoveries, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)