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Study of the Safety, Tolerability, and Pharmacokinetics of NUV001 Administered Orally to Healthy Adult Participants

NCT06133478 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-28

No results posted yet for this study

Summary

This blinded placebo-controlled study is designed to evaluate the safety, tolerability, and PK in healthy participants of a single- and multiple-doses (SAD and MAD) of a new investigational drug: NUV001

Conditions

  • Healthy Volunteers

Interventions

DRUG

NUV001 active cohort 1

6 participants will be assigned to receive active treatment

DRUG

NUV001 active cohort 2

6 participants will be assigned to receive active treatment

DRUG

NUV001 active cohort 3

6 participants will be assigned to receive active treatment

DRUG

NUV001 active cohort 4

6 participants will be assigned to receive active treatment

DRUG

NUV001 placebo cohort 1

2 participants will be assigned to receive placebo

DRUG

NUV001 placebo cohort 2

2 participants will be assigned to receive placebo

DRUG

NUV001 placebo cohort 3

2 participants will be assigned to receive placebo

DRUG

NUV001 placebo cohort 4

2 participants will be assigned to receive placebo

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • LGD

    collaborator INDUSTRY

  • Anapharm

    collaborator INDUSTRY

  • Nuvamid SA

    lead INDUSTRY

Principal Investigators

  • Mary Beth Brune, MD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2024-03-01
Completion
2024-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06133478 on ClinicalTrials.gov