Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-01-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NTP42:KVA4

Group Type EXPERIMENTAL

NTP42:KVA4

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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NTP42:KVA4

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A body mass index (BMI) in the range 18.0-30.0.
* Ability \& willingness to provide written consent.

Exclusion Criteria

* Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
* History of bleeding disorders, coagulation variables or abnormal blood cell count.
* History of chronic illness.
* Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
* History of adverse reaction or allergy to any drug.
* Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
* History of drug or alcohol abuse
* Smoker or use of nicotine-containing products
* Blood pressure or heart rate at screening outside normal ranges.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes