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NMT-CNP8-101

Phase 1 healthy volunteer burn therapy study
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06223009
Recrutement fermé
Dernière modification : 2024/11/13
Type de recherche

Interventionnel

Médicament expérimental

PHASE1


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* BMI between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg.
* Use of highly-effective methods of birth control
* Willing and able to remain in a clinical research unit for the required study duration and return for the outpatient visit

Exclusion Criteria:

* A clinically significant laboratory abnormality or other finding indicative of a clinically-significant exclusionary disease
* A history of asymptomatic or mild COVID within 30 days of study drug administration
* A history of hospitalization with COVID within 6 months prior to study drug administration
* A history of COVID vaccination within 1 month prior to study drug administration

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Single ascending doses of cNP8 Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose. Donnée non disponible
  • Inconnu
  • Single doses of placebo administered Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). Donnée non disponible
  • Inconnu
  • Single ascending doses of cNP8
    État du recrutement
    unknown
    Single doses of placebo administered
    État du recrutement
    unknown
    Données à jour depuis : 13 novembre 2024

    Description de l'étude

    Résumé de l'étude

    This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. The study will consist of a screening period, inpatient dosing and observation period and safety follow-up. Participants will receive 1 intravenous dose of the investigational drug or placebo. Duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.

    Source : Importé depuis le centre

    Up to 32 healthy, male and female subjects will be enrolled in this Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. Eligible subjects will be confined to a Phase 1 unit for approximately 48 hours and receive a one time IV dose of study medication. They will be required to return for a safety follow-up visit one week later.

    Doses will be studied sequentially starting with the lowest dose of the investigational drug, cNP8. Each dose cohort will include a total of 6 subjects dosed with cNP8 and 2 subjects dosed with placebo.

    A sentinel dosing plan with staggered enrollment will be employed. For each dosing cohort, 2 subjects will be dosed (1 with cNP8 and 1 with placebo) and monitored for serious and/or severe adverse events (AEs). If no serious or severe AEs occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed.

    Safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.

    Source : Importé depuis le centre

    Sites

    Centres participants

      1 centres
    • PRISM RESEARCH LLC DBA NUCLEUS NETWORK

      Saint paul

      MINNESOTA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 13 novembre 2024
    Données à jour depuis : 15 nov.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06223009