A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
Recruiting
Phase 1
Interventional Study
Chronic Rhinosinusitis (CRS)
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- VivaVision Biotech, Inc · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Part 1:
* Healthy male or female subjects 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 baseli…
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