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

NCT05127473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers - Haemophilia A

Interventions

DRUG

Mim8 B, 10 mg/mL

All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.

DRUG

Mim8 B, 100 mg/mL

All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.

DRUG

Mim8 B, placebo

Placebo will be used to dilute the IMP to different Mim8 concentrations

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2022-05-14
Completion
2022-05-14

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT05127473 on ClinicalTrials.gov