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Monoclonal Antibodies

Part B: Cohort 4B (SR604 Dose 8) for Healthy Subjects

Q: What is the overall count of participants joining this research investigation?

Affirmative. The details on clinicaltrials.gov specify that this medical research study is actively seeking eligible individuals. Initially shared on April 15, 2024, the most recent update was made on April 22, 2024. A total of 45 participants are sought from a single designated site.

Q: Can individuals younger than 18 years old participate in this research study?

Recruitment for this study is open to individuals aged above 18 years but below 60 years.

Q: Has the regulatory body authorized Part B: Cohort 4B (SR604 Dose 8)?

Given the preliminary nature of this Phase 1 trial, our team rates the safety level of Part B: Cohort 4B (SR604 Dose 8) as a mere 1 on our scale.

Q: Are there any available openings for patients to participate in this medical study?

Affirmative. According to details on clinicaltrials.gov, this research is actively seeking candidates for participation. The study's initial posting was on April 15th, 2024 and its latest update was on April 22nd, 2024. A total of 45 participants are sought from a single designated site.

Q: What specific objectives does this medical study aim to fulfill?

This study aims to assess changes in coagulation markers among participants during Part A (from Day 1 to Day 57) and Part B (from Day 1 up to 3 months). Secondary goals include evaluating the serum concentration-time curve from baseline extrapolated over time, detecting antidrug antibodies, and monitoring drug concentrations before subsequent doses.

Q: Do I meet the necessary criteria to participate in this experimental study?

This trial seeks 45 individuals aged between 18 and 60 diagnosed with Hemophilia A. Eligible participants must have poorly controlled bleeding despite ongoing treatment, be willing to transition from previous Hemophilia A or B therapy, possess medical records detailing at least a two-year history of bleeding events, maintain a body mass index within the range of 18-30 kg/m^2 and weigh between >=50 kg and &#x3C;=90 kg. Furthermore, candidates should present no significant abnormalities upon thorough medical evaluation encompassing physical assessment, electrocardiogram analysis, and laboratory testing. Patients are required to exhibit either Severe congenital Hemophilia A or Se

Phase 1

Recruiting

Research Sponsored by Equilibra Bioscience LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part A: Body mass index between 18 and 30 kg/m^2, weighs >= 50 kg and <= 90 kg

Part A: No clinically significant findings on medical examination including physical examination, 12-lead electrocardiogram, and clinical laboratory tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90

Awards & highlights

Study Summary

This trial will test a new medication called SR604 in two groups of people. The first group will be healthy individuals to see how safe the medication is and how the body processes it. The second group

Who is the study for?

This trial is for individuals with severe Hemophilia A or B whose bleeding isn't controlled well by current treatments, and healthy subjects. Participants must have a BMI of 18-30 kg/m^2, weigh 50-90 kg, and have no significant medical issues. Men must use birth control during the study and for 90 days after.Check my eligibility

What is being tested?

The study tests SR604's safety, how it's tolerated, its movement through and effects on the body (PK/PD) in healthy people (Part A), and those same factors plus effectiveness in those with severe Hemophilia A/B (Part B). Some will receive SR604; others a placebo.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the injection site, headaches, nausea or allergic reactions. The trial aims to assess these potential side effects thoroughly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 18 and 30, and I weigh between 50kg and 90kg.

Select...

My recent health checks, including heart and lab tests, show no significant issues.

Select...

I have severe Hemophilia A or B from birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers

Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf])

Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t])

Part A: Clearance Following Extravascular Administration (CL/F) of SR604

+10 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part B: Cohort 4B (SR604 Dose 8)Experimental Treatment1 Intervention

Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 8 as SC injection.

Group II: Part B: Cohort 3B (SR604 Dose 7)Experimental Treatment1 Intervention

Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 7 as SC injection.

Group III: Part B: Cohort 2B (SR604 Dose 6)Experimental Treatment1 Intervention

Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 6 as SC injection.

Group IV: Part B: Cohort 1B (SR604 Dose 5)Experimental Treatment1 Intervention

Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 5 as SC injection.

Group V: Part A: Cohort 4A (SR604 Dose 4)Experimental Treatment2 Interventions

Participants will receive single SC dose of SR604 dose 4 or matching placebo to SR604 on Day 1.

Group VI: Part A: Cohort 3A (SR604 Dose 3)Experimental Treatment2 Interventions

Participants will receive single SC dose of SR604 dose 3 or matching placebo to SR604 on Day 1.

Group VII: Part A: Cohort 2A (SR604 Dose 2)Experimental Treatment2 Interventions

Participants will receive single SC dose of SR604 dose 2 or matching placebo to SR604 on Day 1.

Group VIII: Part A: Cohort 1A (SR604 Dose 1)Experimental Treatment2 Interventions

Participants will receive single subcutaneous (SC) dose of SR604 dose 1 or matching placebo to SR604 on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Equilibra Bioscience LLCLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall count of participants joining this research investigation?

"Affirmative. The details on clinicaltrials.gov specify that this medical research study is actively seeking eligible individuals. Initially shared on April 15, 2024, the most recent update was made on April 22, 2024. A total of 45 participants are sought from a single designated site."

Answered by AI

Can individuals younger than 18 years old participate in this research study?

"Recruitment for this study is open to individuals aged above 18 years but below 60 years."

Answered by AI

Has the regulatory body authorized Part B: Cohort 4B (SR604 Dose 8)?

"Given the preliminary nature of this Phase 1 trial, our team rates the safety level of Part B: Cohort 4B (SR604 Dose 8) as a mere 1 on our scale."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"Affirmative. According to details on clinicaltrials.gov, this research is actively seeking candidates for participation. The study's initial posting was on April 15th, 2024 and its latest update was on April 22nd, 2024. A total of 45 participants are sought from a single designated site."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"This study aims to assess changes in coagulation markers among participants during Part A (from Day 1 to Day 57) and Part B (from Day 1 up to 3 months). Secondary goals include evaluating the serum concentration-time curve from baseline extrapolated over time, detecting antidrug antibodies, and monitoring drug concentrations before subsequent doses."

Answered by AI

Do I meet the necessary criteria to participate in this experimental study?

"This trial seeks 45 individuals aged between 18 and 60 diagnosed with Hemophilia A. Eligible participants must have poorly controlled bleeding despite ongoing treatment, be willing to transition from previous Hemophilia A or B therapy, possess medical records detailing at least a two-year history of bleeding events, maintain a body mass index within the range of 18-30 kg/m^2 and weigh between >=50 kg and <=90 kg. Furthermore, candidates should present no significant abnormalities upon thorough medical evaluation encompassing physical assessment, electrocardiogram analysis, and laboratory testing. Patients are required to exhibit either Severe congenital Hemophilia A or Se"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B)

2024. "A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06349473.

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