A Study of DISC-3405 in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.

Key facts

Study ID

NCT06050915

Run by

Disc Medicine, Inc

People needed

64

Starts

2023-10-03

Expected to finish

2024-07-09

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female subjects, non-smokers, ages 18-65 (inclusive) at the time of signing the informed consent
• No clinically significant medical history and in good health as determined by detailed medical history
• Body mass index (BMI) 18.0 - 33.0 kg/m2 (inclusive) and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females

You may not qualify if…

• History of severe infection within 4 weeks prior to administration; signs and symptoms of any active infection regardless of severity within 2 weeks prior to administration.
• History of hypersensitivity to similar drugs to DISC-3405 or their excipients.
• Use of any prescription drugs, herbal supplements, or nonprescription drugs, including oral anti-histamines (for seasonal allergies), within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Over-the-counter multivitamins will not be permitted. If needed, paracetamol/acetaminophen (up to 2 grams daily) may be used but must be documented in the Concomitant medications/Significant non-drug therapies page of the source data. Any questions of concomitant medications should be directed to the Sponsor.
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
• Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing
• Pregnant, or nursing females.
• A history of clinically significant psychiatric and psychological condition that, in the judgment of the investigator, may interfere with the planned treatment and follow-up, affect subject compliance, or place the subject at high risk from treatment-related complications
• Abnormal and clinically significant ECG (QT-interval corrected according to Fridericia's formula [QTcF] > 450 msec).
• Clinically significant abnormal vital signs at screening (systolic blood pressure [SBP] <90 mmHg or ≥140 mmHg; diastolic blood pressure [DBP] <50 mmHg or ≥90 mmHg; heart rate <50 beats per minute [bpm] or >100 bpm).
• Clinically significant abnormal laboratory test results or positive serology test results for hepatitis b surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
• Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to study drug administration. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) or live attenuated vaccines and are not allowed.
• Receipt of an immunoglobulin or blood product 90 days prior to dosing
• History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit [more than 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%)] or taking a product containing alcohol 2 days prior to dosing, or positive alcohol breath test at screening.
• History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs [such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives] within 1 year prior to screening.
• Positive urine drug screen, including a cotinine test at screening and on Day -1.
• Active infection with COVID-19. Subjects who have quarantined and are no longer deemed infectious may enroll. Subjects who received a COVID-19 vaccine within 4 weeks prior to dosing, or plan to receive COVID-19 vaccine during the time of their study participation

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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