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HMB-003 Safety Study in Healthy Adults

CT
Overseen ByClinical Trials
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Hemab ApS

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, HMB-003, to assess its tolerance in healthy adults and identify any significant side effects. Researchers seek to determine how much of the drug remains in the body after injection. Participants will receive either a dose of HMB-003 or a placebo, which contains no active drug. The trial seeks healthy individuals without serious medical conditions who have not recently participated in another clinical study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that HMB-003 is likely to be safe for humans?

Research shows that HMB-003 remains in the early testing stages, so complete safety information for humans is not yet available. However, similar compounds have been studied, and reports indicate that HMB (a related compound) is generally safe for both animals and humans. Although specific safety data for HMB-003 is lacking, these findings suggest it might be well-tolerated.

Since this study is in the early phase, the focus is on how well healthy volunteers can handle the drug. This phase involves close monitoring to quickly identify any side effects. If the treatment had already been approved for other conditions, more solid safety evidence would be available. For now, this trial will help gather important safety information.12345

Why do researchers think this study treatment might be promising?

HMB-003 is unique because it introduces a new active ingredient that's being tested for its safety and potential benefits. Unlike current treatments for various conditions that might rely on well-known mechanisms, HMB-003 could offer a fresh approach by potentially targeting different pathways in the body. Researchers are excited about HMB-003 because it may provide an alternative with fewer side effects or improved efficacy, contributing to more personalized and effective treatment options in the future.

What evidence suggests that HMB-003 could be effective?

This trial will evaluate the safety of HMB-003 in healthy adults. Research indicates that HMB-003 aims to provide long-lasting protection against bleeding, particularly for conditions like heavy menstrual bleeding. This treatment targets specific bodily processes that control bleeding. For similar treatments, such as HMB-001, studies have shown a significant reduction in bleeding events. Early lab tests suggest that HMB-003 might also be effective. Although human data on HMB-003 remains limited, its design and related studies offer promising insights into its potential effectiveness.23678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Hemab

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and not taking medications that could interfere with the study.

Inclusion Criteria

I am generally healthy based on recent medical tests and exams.
I am between 18 and 50 years old.

Exclusion Criteria

Participant has a history of clinically significant hypersensitivity to any excipients of the study drug
Participant is pregnant, breastfeeding, or less than 6 weeks postpartum
I have not used any investigational drug or device in the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of HMB-003 or placebo to assess safety, pharmacokinetics, and pharmacodynamics

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HMB-003

Trial Overview

The study is testing a new drug called HMB-003 by giving it to healthy volunteers, while some receive a placebo. The main goals are to check safety, how the body processes the drug, and its effects at different doses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: HMB-003Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hemab ApS

Lead Sponsor

Trials
6
Recruited
1,100+

Citations

HMB-003 - Drug Targets, Indications, Patents

Susceptibility testing showed that it was resistant to all beta-lactams, HMB-003 for Heavy Menstrual Bleeding -002 clinical data demonstrate proof of mechanism ...

Hemab Therapeutics Presents Interim Data from Ongoing ...

Interim results demonstrate treatment with HMB-001 resulted in >50% reduction in treated bleeds at all tested dose levels.

NCT06211634 | A Phase 1/2 Study to Investigate Safety, ...

The goal of this clinical trial is to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with ...

a randomized, double-blind, placebo-controlled study - PMC

Vertical jump power in the HMB-FA group increased 19 % after 12 weeks compared to the placebo group increase of 12 %. The mean vertical jump power was ...

Study on the Safety and Effects of HMB-001 for Patients ...

The purpose of the study is to assess the safety and tolerability of HMB-001 and to explore its potential to reduce the frequency and severity of bleeding ...

A First-in-Human Study to Assess the Safety ...

The purposes of this clinical study are 1. To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, ...

β-Hydroxy-β-Methylbutyrate (HMB) Supplementation in ...

Although several reports in animals and humans indicate that HMB is safe, quantitative safety data in humans have not been reported definitively. The objective ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10917905/

beta-hydroxy-beta-methylbutyrate (HMB) supplementation ...

Although several reports in animals and humans indicate that HMB is safe, quantitative safety data in humans have not been reported definitively. ... 3 g HMB/d.