Your session is about to expire
← Back to Search
Monoclonal Antibodies
A Study of INO-A002 in Healthy Dengue Virus-naive Adults
Phase 1
Waitlist Available
Led By Pablo Tebas, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called dMAb-ZK190 in healthy adults who have never had Dengue fever. The drug is injected into the muscle with a helper enzyme and electrical pulses to help it spread and enter cells. The study aims to see if the drug is safe and how the body processes it.
Eligible Conditions
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the Area Under the Curve (AUC0-t) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation
Determine the maximum serum concentration (Cmax) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.
Determine the minimum serum concentration (Cmin) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort E - 4mg Side PortExperimental Treatment3 Interventions
Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device with Side Port needle.
Group II: Cohort D - 4mgExperimental Treatment3 Interventions
Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Group III: Cohort C - 2mgExperimental Treatment3 Interventions
Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 2 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Group IV: Cohort B - 1mgExperimental Treatment3 Interventions
Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 1 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Group V: Cohort A - 0.5mgExperimental Treatment3 Interventions
Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 0.5 mg DNA/dose. Inoculation will be administered as 0.5 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INO-A002
2019
Completed Phase 1
~30
CELLECTRA® 2000
2020
Completed Phase 2
~350
Dengue Fever Antibodies (IgG)
2019
Completed Phase 1
~30
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,503 Total Patients Enrolled
Inovio PharmaceuticalsIndustry Sponsor
53 Previous Clinical Trials
4,775 Total Patients Enrolled
Pablo Tebas, MDPrincipal InvestigatorUniversity of Pennsylvania
18 Previous Clinical Trials
571 Total Patients Enrolled