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Tests treatment safety and results for Chronic Rhinosinusitis (CRS)
Official title A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
ClinicalTrials.gov ID: NCT07259538
What this study is testing
What is 0.5% VVN432 Nasal Spray?
0.5% VVN432 Nasal Spray is an investigational medicine, being studied as a potential treatment for chronic rhinosinusitis (crs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VVN432 Nasal Spray in healthy volunteers (Phase Ia) and in patients with chronic rhinosinusitis (Phase 1b). This study consists of two parts (Phase 1a and Phase 1b): Phase 1a (SAD) is a single-center, randomized, double-masked, vehicle-controlled study to assess the safety, tolerability, and PK of VVN432 Nasal Spray in healthy adult subjects.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Part 1:
- Healthy male or female people aged 18 to 55 years old (inclusive);
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 18.5 to 28.0 kg/m2 (inclusive);
- No clinically significant abnormalities at screening or baseline. Part 2:
- Male or female patients aged 18 to 55 years old (inclusive);
You likely can't join if
- Part 1:
- Known hypersensitivity or contraindications to the study drug or its components;
- History or current conditions that affect the safety or absorption of the investigational drug;
- History of drug abuse or drug dependence;
- Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is...
- If female, is pregnant or lactating, or intends to become pregnant during the study period. Part 2:
See the full eligibility criteria
- Part 1:
- Healthy male or female people aged 18 to 55 years old (inclusive);
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 18.5 to 28.0 kg/m2 (inclusive);
- No clinically significant abnormalities at screening or baseline. Part 2:
- Male or female patients aged 18 to 55 years old (inclusive);
- Clinically confirmed diagnosis of chronic rhinosinusitis with or without nasal polyps;
- Presence of the following symptoms for \>4 weeks before screening: nasal obstruction, mucous or mucopurulent rhinorrhea, facial pain/pressure, and reduced or lost sense of smell;
- Modified Lund-Kennedy (MLK) score ≥ 2 in each nostril by nasal endoscopy;
- Lund-Mackay score (LMK) ≥ 2 in each nostril by CT scan;
- Nasal Construction Score (NCS) ≥ 2.
- Part 1:
- Known hypersensitivity or contraindications to the study drug or its components;
- History or current conditions that affect the safety or absorption of the investigational drug;
- History of drug abuse or drug dependence;
- Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is longer;
- If female, is pregnant or lactating, or intends to become pregnant during the study period. Part 2:
- Known hypersensitivity or contraindications to the study drug or its components;
- Use of prohibited medications prior to screening and during the course of the study; History of drug abuse or drug dependence;
- Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is longer;
- If female, is pregnant or lactating, or intends to become pregnant during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.