A Phase 1/2, Randomized, Placebo-Controlled, Double-Blind, Dose-Finding, First-in-Human Study of Respiratory Syncytial Virus (RSV) mRNA Vaccine STR-V003 in Healthy Adults

Starna Therapeutics0 sites48 target enrollmentMay 2024

ConditionsRespiratory Syncytial Virus Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Starna Therapeutics
Enrollment: 48
Primary Endpoint: Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2024

End Date

May 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Starna Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to understand and willing to sign the ICF.
•Healthy male and female subjects, non-smokers defined as having abstained from tobaccoornicotine containing products (e.g., cigarettes, chewing tobacco, snuff, nicotine patches,and electronic cigarettes) in the 6 months prior to the Screening.
•Must be ≥18 years of age.
•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
•Be a female of non-childbearing potential \[i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and have an FSH \> 40mIU/mL, or surgically sterile (defined as having a bilateral oophorectomy, hysterectomy or tubal ligation)\] or agree to one of the following to prevent pregnancy.
•If a woman of childbearing potential, she must have a negative serum pregnancy test at screening:

Exclusion Criteria

•Pregnancy or lactation.
•History or presence of conditions which, in the judgment of the Investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
•History of any clinically significant medical illness or medical disorders the Investigator considers should exclude the subject, including (but not limited to) immune deficient state; neuromuscular, hematological, cardiac, vascular, metabolic, endocrine, rheumatologic,respiratory, hepatic, gastrointestinal, neurological, neoplastic, dermatological, renal, urinary tract, or psychiatric disease, hypertension, osteoarthritis or ophthalmological disorders.
•Clinically significant abnormalities on ECG, including a QT corrected according to Fridericia's formula (QTcF) interval \> 450 msec (males) or \> 470 msec (for females).
•History of surgery or major trauma within 6 months prior to study screening.
•History of any significant hypersensitivity reaction to medications, including manifestations suggestive of anaphylaxis.
•History or presence of any active infection within 14 days, or an infection requiring prescription therapy or hospitalization within 30 days of enrollment.
•History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse or addiction within 12 months of Screening.
•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.

Outcomes

Primary Outcomes

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

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

Immediate unsolicited AEs for 30 minutes post-vaccination

Time Frame: 30 minutes

Percentage of Participants With Immediate unsolicited AEs Through 30 minutes After Initial Vaccination

Solicited injection site (local) and systemic reactions for 7 days postvaccination.

Time Frame: 7 days

Percentage of Participants With Solicited injection site (local) and systemic reactions for 7 days After Initial Vaccination

Unsolicited AEs for 28 days postvaccination

Time Frame: 28 days

Percentage of Participants With Unsolicited AEs for 28 days After Initial Vaccination