Status:
COMPLETED
A Study of DISC-3405 in Healthy Volunteers
Lead Sponsor:
Disc Medicine, Inc
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.
Detailed Description
Each enrolled subject will receive one single or multiple doses of DISC-3405 or placebo. During the study, subjects will be evaluated for safety and tolerability, pharmacokinetics (PK), pharmacodynami...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06050915
Start Date
October 3 2023
End Date
July 9 2024
Last Update
December 18 2024
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502