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A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray

ConditionChronic Rhinosinusitis (CRS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVivaVision Biotech, Inc

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 of VVN432 Nasal Spray in healthy adult subjects.

Phase 1b (MAD) is a multi-center, randomized, double-masked, vehicle-controlled study to assess the safety, tolerability, PK/PD, and preliminary efficacy of VVN432 Nasal Spray in patients with chronic rhinosinusitis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 baseline.

Male or female patients aged 18 to 55 years old (inclusive);

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • 0.5% VVN432 Nasal Spray

    Drug

    0.5% VVN432 Nasal Spray

  • 1% VVN432 Nasal Spray

    Drug

    1% VVN432 Nasal Spray

  • Vehicle

    Drug

    VVN432 Nasal Spray, Placebo

Treatment groups

60 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril)Experimental treatment 1 intervention
Group B: Part 1: 1% VVN432 Nasal Spray (1 spray/nostril)Experimental treatment 1 intervention
Group C: Part 1: 1% VVN432 Nasal Spray (2 spray/nostril)Experimental treatment 1 intervention
Group D: Part 1: VehiclePlacebo comparator 1 intervention
Group E: Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril)Experimental treatment 1 intervention
Group F: Part 2: 1% VVN432 Nasal Spray (1 spray/nostril)Experimental treatment 1 intervention
Group G: Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril)Experimental treatment 1 intervention
Group H: Part 2: VehiclePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray.

Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECG, and vital signs

Time frame
Baseline to Day 10
2

Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray

Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECT, and vital signs

Time frame
Baseline to Day 35

Secondary outcomes

1

Part 1: To evaluate the systemic PK of VVN432 Nasal Spray

Plasma concentration of VVN432, and assess the PK parameters if applicable

Time frame
48 hours
2

Part 1: To evaluate the local PK of VVN432 Nasal Spray

Local concentration of VVN432 in the eluent of oropharyngeal swabs and nasal swabs, and in nasal lavage fluid post-dose

Time frame
48 hours
3

Part 2: To evaluate the systemic PK of VVN432 Nasal Spray

Plasma concentration of VVN432, and assess the PK parameters if applicable

Time frame
Day 1, Day 28, and Day 35
4

Part 2: To evaluate the local PK of VVN432 Nasal Spray

Local concentration of VVN432 in the eluent of nasal swabs post-dose

Time frame
Day 1, Day 28, and Day 35

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VivaVision Biotech, Inc

Lead sponsor

Source ClinicalTrials.gov
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