A Study of DISC-3405 in Healthy Volunteers

NCT06050915 | Completed Phase 1 FDA Drug

• 1 other identifier: DISC-3405-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

  up to 99 days

• Incidence of treatment-emergent clinically abnormal physical exam

  up to 99 days

• Incidence of treatment-emergent clinically significant laboratory test results

  up to 99 days

• Incidence of treatment-emergent clinically significant electrocardiograms (ECGs)

  up to 99 days

• Incidence of treatment-emergent clinically abnormal vital signs

  up to 99 days

Secondary Outcomes (12)

• Plasma maximum measured drug concentration (Cmax)

  up to 99 days

• Time of maximum concentration (Tmax)

  up to 99 days

• Area under the concentration-time curve from dosing to the last measurable time point (AUC0-t)

  up to 99 days

• Area under the concentration-time curve from dosing to infinity (AUC0-∞)

  up to 99 days

• Drug elimination half-life (T½ el)

  up to 99 days

Study Arms (4)

Single Ascending Dose of DISC-3405

EXPERIMENTAL

Drug: DISC-3405

Single Ascending Dose of Placebo

PLACEBO COMPARATOR

Drug: Placebo

Multiple Ascending Dose of DISC-3405

EXPERIMENTAL

Drug: DISC-3405

Multiple Ascending Dose of Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DISC-3405 DRUG

DISC-3405 is administered as a single dose IV infusion or subcutaneous injection

Also known as: 9MW3011

Single Ascending Dose of DISC-3405

Placebo DRUG

Placebo is administered as a single dose IV infusion or subcutaneous injection

Single Ascending Dose of Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Disc Medicine, Inc: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Will Savage, MD PhD

  Disc Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 22, 2023
• Study Start: October 3, 2023
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)