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

A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Male Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; Drug: SD-101

Detailed Description

This is a Phase 1, randomized, single-blind, placebo-controlled study of five escalating dose levels of SD-101 in healthy male volunteers. The objectives of the study are to assess the safety, tolerability, pharmacokinetic profile, and pharmacodynamics of SD-101. Approximately 40 subjects will participate.

Once subjects have been consented, screened, and assigned to one of the dose levels of SD-101, subjects will receive a single subcutaneous injection of either SD-101 or placebo (PBS) in a ratio of 6:2.

Safety and tolerability will be evaluated by occurrence of adverse events, blood and urine laboratory tests, physical examination findings, vital signs , and electrocardiogram findings. Pharmacodynamics will be evaluated by levels of blood biomarkers and serum cytokines, and flow cytometric cell counts. Pharmacokinetics will be evaluated by levels of study drug in serum.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Healthcare Discoveries, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo; placebo
EXPERIMENTAL: Escalating Dose of SD-101	Drug: SD-101; Single subcutaneous escalating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dynavax Technologies Corporation
• Investigators: Principal Investigator: Dennis Ruff, MD, Healthcare Discoveries, Inc.

Publications and helpful links

Helpful Links

• sponsor website

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (ESTIMATE): January 23, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: healthy volunteer; phase 1; Immunostimulatory sequence (ISS); research subjects
• Other Study ID Numbers: DV3-HNV-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No Change to status of this study.