A Phase 1/2 interventional study of STR-V003/Placebo in Respiratory Syncytial Virus Infections, sponsored by Starna Therapeutics. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Starna Therapeutics · Phase 1/2, Interventional, and Prevention
This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Starna Therapeutics is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic,psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physicalexamination, vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening.
4.1) Abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading.
4.2) Abnormalities found in the ECG may need to be confirmed by repeated measurements.
Subjects must have adequate organ function according to the following laboratory values:
5.1) Bone marrow function (absolute neutrophil count ≥ 1500/mm3 and platelet count ≥100,000/mm3) 5.2) Adequate liver function [alanine aminotransferase (ALT) ≤ 1.5 × upper limit normal(ULN) and alkaline phosphatase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 mg/dL] 5.3) Adequate renal function creatinine clearance 60 mL/min based on Cockcroft-Gaultequation, or serum creatinine level ≤ 1.5 times the ULN
If a woman of childbearing potential, she must have a negative serum pregnancy test at screening:
7.1) Practicing abstinence. 7.2) If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) she must agrees to prevent pregnancy by using double methods of contraception as until at least 6 months after the last dose of the investigational product.
Exclusion Criteria:
Use of prescription medications within 30 days or 5 half-lives, whichever is longer, prior to administration of the study drug.
9.1) Hormonal birth control will be permitted.
Cohort 1: Dose A in Younger/older Adults Single injection of Dose A of STR-V003 or placebo on Day 0.
Biological: STR-V003/Placebo
Cohort 2: Dose B in Younger/older Adults Single injection of Dose B of STR-V003 or placebo on Day 0.
Biological: STR-V003/Placebo
Cohort 3: Dose C in Younger/older Adults Single injection of Dose C of STR-V003 or placebo on Day 0.
Biological: STR-V003/Placebo
Cohort 4: Dose B in Younger/older Adults Two injections of Dose B of STR-V003 or placebo on Day 0 and Day21.
Biological: STR-V003/Placebo
IM
Immediate unsolicited AEs for 30 minutes post-vaccination
Percentage of Participants With Immediate unsolicited AEs Through 30 minutes After Initial Vaccination
Time frame: 30 minutes
Solicited injection site (local) and systemic reactions for 7 days postvaccination.
Percentage of Participants With Solicited injection site (local) and systemic reactions for 7 days After Initial Vaccination
Time frame: 7 days
Unsolicited AEs for 28 days postvaccination
Percentage of Participants With Unsolicited AEs for 28 days After Initial Vaccination
Time frame: 28 days
Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration
Percentage of Participants With Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Respiratory Syncytial Virus Infections→
Starna Therapeutics