NCT05127473 is a Phase 1 clinical trial of Mim8 B, 10 mg/mL in Healthy Volunteers - Haemophilia A, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT05127473?

NCT05127473 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT05127473?

Interventions in NCT05127473: Mim8 B, 10 mg/mL, Mim8 B, 100 mg/mL, Mim8 B, placebo.

What condition does NCT05127473 study?

NCT05127473 studies Healthy Volunteers - Haemophilia A.

Is NCT05127473 still recruiting?

NCT05127473 is currently completed. Last updated 1 November 2023.

Last reviewed 2023-11-01 · How we verify

NCT05127473

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

A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People

Completed Phase 1 Last updated 1 November 2023

What this trial tests

Phase 1 trial testing Mim8 B, 10 mg/mL in Healthy Volunteers - Haemophilia A in 66 participants. Completed in 14 May 2022.

Timeline

14 July 2021

Primary endpoint
14 May 2022

14 May 2022

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	14 July 2021
Primary completion	14 May 2022
Estimated completion	14 May 2022
Sites	2 locations across Germany

Drugs / interventions tested

Mim8 B, 10 mg/mL — full drug profile →
Mim8 B, 100 mg/mL — full drug profile →
Mim8 B, placebo — full drug profile →

Conditions studied

Healthy Volunteers - Haemophilia A — all drugs for Healthy Volunteers - Haemophilia A →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy Volunteers - Haemophilia A. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly). This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body. Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle. The study will last for about 17 - 21 weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Updates on Novel Non-Replacement Drugs for Hemophilia.
Gualtierotti R, Pasca S, Ciavarella A, Arcudi S, et al · · 2022 · cited 22× · PMID 36297295 · DOI 10.3390/ph15101183
Mim8, a novel factor VIIIa mimetic bispecific antibody, shows favorable safety and pharmacokinetics in healthy adults.
Persson P, Amstrup AB, Coester HV, Matytsina I, et al · · 2023 · cited 18× · PMID 37745159 · DOI 10.1016/j.rpth.2023.102181

Verify or expand the search:

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

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 NCT05127473 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 1 November 2023

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/NCT05127473.

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