NCT06033612

Safety, Tolerability, Pharmacokinetics, and Food Effect Study of RV299 in Healthy Adults

A Randomised, Double Blinded, Placebo-controlled Single and Multiple Ascending Dose Study of Orally Administered RV299 to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The main aims of the study are to assess the safety, tolerability, pharmacokinetics and food effects of RV299 compared to Placebo in healthy adult participants. The study consists of three parts: single ascending dose (Part A), multiple ascending doses (Part B) and food effect (Part C) in Caucasian participants.

Detailed description

This is a randomised, double blind, placebo-controlled Phase I study to assess the safety, tolerability, pharmacokinetics and food effect of RV299 in healthy participants aged ≥ 20 to ≤ 40 years. The clinical study consists of 3 parts (Parts A - C): Part A: single ascending doses (SAD) of RV299 in healthy adult Caucasian participants (up to 3 dose levels of RV299 in 3 cohorts; 6 participants/cohort) Part B: multiple ascending doses (MAD) of RV299 in healthy adult Caucasian participants (up to 2 dose levels of RV299 in 2 cohorts of 8 participants dosed for 5 consecutive days). Part B will incorporate a drug-drug interaction (DDI) design to investigate interaction between RV299 and midazolam in one cohort (Cohort 3) of 8 participants. Part C: food effect (FE) in healthy adult Caucasian participants (one cohort of 8 participants to be randomised to receive either RV299 in the first treatment period fasted and in the second treatment period fed, or vice versa) The study will be conducted as an adaptive integrated design since various study parts can be triggered at appropriate times during the conduct of other parts of the study. Dose escalation to the following scheduled dose or progression to a consecutive part of the study will only occur after satisfactory review of all safety, tolerability and pharmacokinetic (PK) data.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	RV299	Oral Suspension
DRUG	Placebo	matching placebo
DRUG	Midazolam	pre-filled oral syringe

Timeline

• Start date: 2021-11-12
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: United Kingdom