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A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)

A Phase 1b Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-3405 in Participants With Sickle Cell Disease

NCT07187973•Disc Medicine, Inc

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, within-participant dose-escalation study examining up to 3 dose levels of DISC-3405 and will assess the safety, tolerability, PK, and PD of DISC 3405 in participants with sickle cell disease.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older at the time of signing the informed consent form (ICF).
•2. Male or female study participants with SCD HbSC or HbSS.
•3. Participants who have been diagnosed with any of the following SCD-related complications: between 1-10 episodes of VOC in the past 12 months, any history of sickle cell related retinopathy, silent cerebral infarct, avascular necrosis, sensorineural hearing loss; or at least 1 episode of priapism, hepatic sequestration, splenic sequestration, or splenic infarct within the last 12 months as assessed locally.
•4. Hgb ≥7.0 g/dL during Screening. The first 2 participants must have an Hgb ≥9 g/dL.
•5. Normal alpha globin gene screen.
•6. Absolute reticulocyte count or % reticulocyte count \>1.5 × upper limit of normal (ULN) during Screening.
•7. TSAT ≥15% at Screening.
•8. Ferritin ≥50 ng/mL for HbSC or ≥100 ng/mL for HbSS (ferritin must be \<1000 ng/mL at Screening).
•9. For participants taking hydroxyurea, L-glutamine, or crizanlizumab, stable dose for at least 2 months prior to Screening and with no anticipated need for dose adjustments during the study.
•10. If male, not vasectomized for at least 6 months, with female sexual partner(s) of childbearing potential, agrees he and partner will use double methods of the following highly effective methods of birth control (described below) from the first dose of randomized study drug until 120 days after the last administration of study drug and must not donate sperm during their study participation:
+10 more criteria

Exclusion Criteria

•1. Participants who are receiving regularly scheduled blood (RBC) transfusion therapy or phlebotomy or have received RBC transfusion or phlebotomy within 60 days of Screening.
•2. Hospitalized for VOC or other sickle cell related complication within 14 days of Screening.
•3. Participants with clinically significant bacterial, fungal, parasitic, or viral infection.
•4. Active HIV, hepatitis B, or C. A positive hepatitis or HIV result should be discussed between the Investigator and Sponsor prior to enrollment.
•5. Significant renal dysfunction, evidenced by estimated glomerular filtration rate of \<60 mL/min/1.73 m2 at the Screening visit, as assessed locally.
•6. Hepatic dysfunction characterized by alanine aminotransferase (ALT) \>2.5 × ULN.
•7. Any episode of ACS in the last 6 months.
•8. Prior or planned hematopoietic stem cell transplant or gene therapy.
•9. History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to Screening.
•10. History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer, or other malignancies deemed acceptable by the Sponsor.
+8 more criteria

Locations (1)

Julie Kanter

Birmingham, Alabama, United States

Key Dates

Start Date

January 6, 2026

Primary Completion Date

June 1, 2027

Completion Date

October 1, 2027

Last Updated

February 3, 2026

Enrollment

ESTIMATED participants

Conditions

Sickle Cell Disease

Interventions

DISC-3405

DRUG

Contacts

Disc Medicine Clinical Trials

CONTACT

(617) 674 9274 clinicaltrials@discmedicine.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)

Inclusion Criteria

Exclusion Criteria

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