Healthy VolunteerPhase 1NCT06050915
A Study of DISC-3405 in Healthy Volunteers
A Phase 1 study testing DISC-3405 in people with Healthy Volunteer, run by Disc Medicine, Inc at 1 site in United States.
Trial summary
This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- DISC-3405
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 9 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Characteristics of DISC-3405 in Adult Healthy Male and Female Volunteers
This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.
Read the 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), pharmacodynamics (PD), and immunogenicity of DISC-3405. In the single ascending dose (SAD) phase, a sentinel group of two subjects will be dosed first: one with DISC-3405, and the other with placebo; the randomization and blinding will be maintained. The remaining subjects for the cohort will be dosed at least 24 hours after the last sentinel dosing following approval from the principal investigator.
Subsequent multiple ascending dose (MAD) cohorts will only enroll after a sufficient safety observation period for the SAD cohort, accordingly there will be no sentinel participants for cohorts in MAD.
DISC-3405 or placebo will be administered as an IV infusion or subcutaneous injection. Subjects will have end-of-study (EOS) follow-up visits on Day 99 after the last administration.
- Conditions
- Healthy Volunteer
- Being tested
- DISC-3405, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISC-3405Drug
Also called 9MW3011
DISC-3405 is administered as a single dose IV infusion or subcutaneous injection
DISC-3405Drug
Also called 9MW3011
DISC-3405 is administered in multiple ascending doses as an IV infusion or subcutaneous injection
PlaceboDrug
Placebo is administered as a single dose IV infusion or subcutaneous injection
PlaceboDrug
Placebo is administered in multiple ascending doses as an IV infusion or subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose of DISC-3405 | Experimental | Not described Receives: Drug: DISC-3405 |
| Single Ascending Dose of Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Multiple Ascending Dose of DISC-3405 | Experimental | Not described Receives: Drug: DISC-3405 |
| Multiple Ascending Dose of Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: up to 99 days
Incidence of treatment-emergent clinically abnormal physical exam
Measured: up to 99 days
Incidence of treatment-emergent clinically significant laboratory test results
Measured: up to 99 days
Incidence of treatment-emergent clinically significant electrocardiograms (ECGs)
Measured: up to 99 days
Incidence of treatment-emergent clinically abnormal vital signs
Measured: up to 99 days
Secondary outcomes (12)
Plasma maximum measured drug concentration (Cmax)
Measured: up to 99 days
Time of maximum concentration (Tmax)
Measured: up to 99 days
Area under the concentration-time curve from dosing to the last measurable time point (AUC0-t)
Measured: up to 99 days
Area under the concentration-time curve from dosing to infinity (AUC0-∞)
Measured: up to 99 days
Drug elimination half-life (T½ el)
Measured: up to 99 days
Volume of plasma cleared (CL)
Measured: up to 99 days
Trough Concentration (Ctrough)
Measured: up to 99 days
Volume of Distribution (Vd)
Measured: up to 99 days
Elimination rate constant (Kel)
Measured: up to 99 days
Change from baseline of hepcidin levels
Measured: up to 99 days
Change from baseline in transferrin saturation (TSAT) levels
Measured: up to 99 days
Change from baseline of serum iron levels
Measured: up to 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start3 Oct 2023
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Disc Medicine, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Will Savage, MD PhD, Study director, Disc Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050915
- Sponsor's protocol ID
- DISC-3405-101
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Characteristics of DISC-3405 in Adult Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT06050915
- Acronym / sponsor ID
- DISC-3405-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Disc Medicine, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), pharmacodynamics (PD), and immunogenicity of DISC-3405. In the single ascending dose (SAD) phase, a sentinel group of two subjects will be dosed first: one with DISC-3405, and the other with placebo; the randomization and blinding will be maintained. The remaining subjects for the cohort will be dosed at least 24 hours after the last sentinel dosing following approval from the principal investigator.
Subsequent multiple ascending dose (MAD) cohorts will only enroll after a sufficient safety observation period for the SAD cohort, accordingly there will be no sentinel participants for cohorts in MAD.
DISC-3405 or placebo will be administered as an IV infusion or subcutaneous injection. Subjects will have end-of-study (EOS) follow-up visits on Day 99 after the last administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISC-3405Also: 9MW3011DISC-3405 is administered as a single dose IV infusion or subcutaneous injection | Drug | Single Ascending Dose of DISC-3405 |
| DISC-3405Also: 9MW3011DISC-3405 is administered in multiple ascending doses as an IV infusion or subcutaneous injection | Drug | Multiple Ascending Dose of DISC-3405 |
| PlaceboPlacebo is administered as a single dose IV infusion or subcutaneous injection | Drug | Single Ascending Dose of Placebo |
| PlaceboPlacebo is administered in multiple ascending doses as an IV infusion or subcutaneous injection | Drug | Multiple Ascending Dose of Placebo |
Primary outcome
Incidence of adverse events
Time frame: up to 99 days
Incidence of treatment-emergent clinically abnormal physical exam
Time frame: up to 99 days
Incidence of treatment-emergent clinically significant laboratory test results
Time frame: up to 99 days
Incidence of treatment-emergent clinically significant electrocardiograms (ECGs)
Time frame: up to 99 days
Incidence of treatment-emergent clinically abnormal vital signs
Time frame: up to 99 days
12 secondary outcomes
Plasma maximum measured drug concentration (Cmax)
Time frame: up to 99 days
Time of maximum concentration (Tmax)
Time frame: up to 99 days
Area under the concentration-time curve from dosing to the last measurable time point (AUC0-t)
Time frame: up to 99 days
Area under the concentration-time curve from dosing to infinity (AUC0-∞)
Time frame: up to 99 days
Drug elimination half-life (T½ el)
Time frame: up to 99 days
Volume of plasma cleared (CL)
Time frame: up to 99 days
Trough Concentration (Ctrough)
Time frame: up to 99 days
Volume of Distribution (Vd)
Time frame: up to 99 days
Elimination rate constant (Kel)
Time frame: up to 99 days
Change from baseline of hepcidin levels
Time frame: up to 99 days
Change from baseline in transferrin saturation (TSAT) levels
Time frame: up to 99 days
Change from baseline of serum iron levels
Time frame: up to 99 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Will Savage, MD PhD study director
Disc Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DISC-3405 in people with Healthy Volunteer, run by Disc Medicine, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: up to 99 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.