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Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

NCT04919863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-02-24

No results posted yet for this study

Summary

A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.

Conditions

  • Healthy

Interventions

DRUG

NTP42:KVA4

Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.

DRUG

Placebo

Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • ATXA Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Malcolm Boyce, MD · Hammersmith Medicines Reserach

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2022-01-20
Completion
2022-01-20

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919863 on ClinicalTrials.gov