NCT04845321

Brief Summary

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

April 10, 2021

Last Update Submit

June 4, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Part 1: Number of subjects with adverse events

    Up to 8 days after last administration of study drug

  • Part 2: Number of subjects with adverse events

    Up to 8 days after last administration of study drug

Secondary Outcomes (9)

  • Part 1: AUC0-tau

    Days 1-6 (Days 1-12 for fasted/fed cohort)

  • Part 1: Cmax

    Days 1-6 (Days 1-12 for fasted/fed cohort)

  • Part 1: tmax

    Days 1-6 (Days 1-12 for fasted/fed cohort)

  • Part 1: AUCinf

    Days 1-6 (Days 1-12 for fasted/fed cohort)

  • Part 1: t1/2

    Days 1-6 (Days 1-12 for fasted/fed cohort)

  • +4 more secondary outcomes

Study Arms (2)

VNRX-9945

EXPERIMENTAL

Oral dosing

Drug: VNRX-9945

Placebo

PLACEBO COMPARATOR

Oral dosing

Drug: Placebo for VNRX-9945

Interventions

VNRX-9945DRUG

Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

VNRX-9945
Placebo for VNRX-9945DRUG

Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults 18-55 years
  • Males or non-pregnant, non-lactating females
  • Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight \>50 kg (110 lbs)
  • Normal blood pressure
  • Normal lab tests

You may not qualify if:

  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • History of severe allergic or anaphylactic reaction
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Positive alcohol, drug, or tobacco use/test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Zealand Clinical Research

Auckland, New Zealand

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 14, 2021

Study Start

June 23, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

NZ(1)