NCT05642546 is a Phase 1 clinical trial of NM8074 in Healthy, sponsored by NovelMed Therapeutics.

Who is sponsoring NCT05642546?

NCT05642546 is sponsored by NovelMed Therapeutics.

What drugs are being tested in NCT05642546?

Interventions in NCT05642546: NM8074, Placebo.

Is NCT05642546 still recruiting?

NCT05642546 is currently completed. Last updated 8 December 2022.

Last reviewed 2022-12-08 · How we verify

NCT05642546

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers

Completed Phase 1 Last updated 8 December 2022

What this trial tests

Phase 1 trial testing NM8074 in Healthy in 40 participants. Completed in 15 June 2022.

Timeline

12 August 2020

Primary endpoint
15 June 2022

15 June 2022

Quick facts

Lead sponsor	NovelMed Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	12 August 2020
Primary completion	15 June 2022
Estimated completion	15 June 2022
Sites	1 location across United States

Drugs / interventions tested

NM8074 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

NovelMed Therapeutics — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074 to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05642546 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NovelMed Therapeutics
Last refreshed: 8 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05642546.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing