Healthy VolunteerPhase 1NCT04999527
Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects
A Phase 1 study testing DISC-0974 in people with Healthy Volunteer, run by Disc Medicine, Inc at 1 site in United States.
Trial summary
This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult 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-0974
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 30 Jun 2022
- 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
- Male or female (HV only) adults aged 18 to 65 years, inclusive at the time of consent.
- Body weight ≥50 kg and body mass index (BMI) between 18 and 33, inclusive, at Screening.
- Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 at Screening.
- No clinically significant abnormalities as determined by medical history, by results of physical examination, vital signs, ECG and lab tests at Screening.
- QTcF <450 msec at Screening.
- Estimated glomerular filtration rate >60 mL/min/1.73m2 based on the 4 parameter MDRD (Modification of Diet in Renal Disease) equation at Screening
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- TSAT ≤30% at Screening, as determined in a fasting morning blood sample (06:00 to 11:00 hours).
- Hematologic parameters (red blood cell count [RBC], hemoglobin, hematocrit, platelet count, mean corpuscular volume, mean corpuscular hemoglobin concentration), serum iron, and TIBC within normal range and serum ferritin (within normal range and ≥30 ng/mL) at Screening.
- If a male with female sexual partner(s) of childbearing potential, must agree to use acceptable methods of birth control during the study and through the End of Study (EOS) visit
- If female, postmenopausal, as defined with at least 12 months natural, spontaneous amenorrhea, or at least 6 weeks following surgical menopause
- Able to understand and provide written informed consent and comply with protocol requirements
Who cannot join
- History of anemia or hematologic disorder within 1 year of Screening
- History of splenectomy
- Diagnosis or first-degree relative with a diagnosis of hemochromatosis
- History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease
- Vegan or iron-deficient diet within 3 months of Screening
- Blood transfusion within 1 year of Screening
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- Whole blood donation within 6 months of Screening or plasma donation within 30 days of Screening.
- A history of alcohol or illicit drug use disorder within 3 years of Screening, as assessed by the Investigator
- Use of any tobacco- and/or nicotine-containing containing products, including e-cigarettes, vaping products, and nicotine replacement products, within 3 months of Screening
- Use of multivitamin or iron supplements within 30 days prior to Screening
- ALT or aspartate aminotransferase (AST) level above the normal range at Screening
- Positive urine pregnancy test at Screening or Baseline (Day -1).
- Positive serologic test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening.
- Positive urine screen for drugs of abuse or alcohol test on admission to the study center
- Use of any systemic prescription medication within 14 days of Screening, non-iron containing dietary supplements, or non-prescription drugs within 7 days of dosing.
- History of a major surgical procedure within 60 days of Screening or planned surgical procedure within 90 days of dosing.
- A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.
- History or presence or any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects Following Dose-Escalating Single Intravenous or Subcutaneous Administration
This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.
Read the detailed description
Enrolled participants in this study will receive a single dose of DISC-0974 or a placebo. Samples will be collected to measure how DISC-0974 is processed by the body and how the body responds when exposed to DISC-0974. Participants will receive a single study drug dose on Day 1; and follow-up for 10 weeks (71 days). If an undetectable DISC-0974 blood concentration is observed, the duration of follow-up will be shortened to 7 days thereafter, as feasible.
- Conditions
- Healthy Volunteer
- Being tested
- DISC-0974, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISC-0974Drug
DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose
PlaceboDrug
Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer: Single Ascending Dose of DISC-0974 | Experimental | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers Receives: Drug: DISC-0974 |
| Healthy Volunteer: Single Ascending Dose of Placebo | Experimental | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers 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 71 days of monitoring
Incidence of abnormal laboratory test results
Measured: Up to 71 days of monitoring
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
Measured: Up to 71 days of monitoring
Incidence of treatment-emergent clinically abnormal physical exam
Measured: Up to 71 days of monitoring
Secondary outcomes (4)
Plasma maximum measured drug concentration (Cmax)
Measured: Up to 71 days of testing
Time of maximum concentration (Tmax)
Measured: Up to 71 days of testing
Area under the concentration-time curve (AUC)
Measured: Up to 71 days of testing
Plasma half-life (T½)
Measured: Up to 71 days of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start10 Aug 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Disc Medicine, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Savage, MD, PhD, Study director, Disc Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999527
- Sponsor's protocol ID
- DISC-0974-101
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Novikov N, Buch A, Yang H, Andruk M, Liu G, Wu M, Howell H, MacDonald B, Savage W. First-in-Human Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of DISC-0974, an Anti-Hemojuvelin Antibody, in Healthy Participants. J Clin Pharmacol. 2024 Aug;64(8):953-962. doi: 10.1002/jcph.2432. Epub 2024 Mar 21.
PubMed 38515275
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects Following Dose-Escalating Single Intravenous or Subcutaneous Administration
- ClinicalTrials.gov ID
- NCT04999527
- Acronym / sponsor ID
- DISC-0974-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Disc Medicine, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Aug 2021 (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 of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.
Detailed description
Enrolled participants in this study will receive a single dose of DISC-0974 or a placebo. Samples will be collected to measure how DISC-0974 is processed by the body and how the body responds when exposed to DISC-0974. Participants will receive a single study drug dose on Day 1; and follow-up for 10 weeks (71 days). If an undetectable DISC-0974 blood concentration is observed, the duration of follow-up will be shortened to 7 days thereafter, as feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer: Single Ascending Dose of DISC-0974 | Experimental | Drug: DISC-0974Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
| Healthy Volunteer: Single Ascending Dose of Placebo | Experimental | Drug: PlaceboSingle Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female (HV only) adults aged 18 to 65 years, inclusive at the time of consent.
- Body weight ≥50 kg and body mass index (BMI) between 18 and 33, inclusive, at Screening.
- Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 at Screening.
- No clinically significant abnormalities as determined by medical history, by results of physical examination, vital signs, ECG and lab tests at Screening.
- QTcF <450 msec at Screening.
Key exclusion criteria (18 listed)
- History of anemia or hematologic disorder within 1 year of Screening
- History of splenectomy
- Diagnosis or first-degree relative with a diagnosis of hemochromatosis
- History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease
- Vegan or iron-deficient diet within 3 months of Screening
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-0974DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose | Drug | Healthy Volunteer: Single Ascending Dose of DISC-0974 |
| PlaceboPlacebo is administered (IV infusion or Subcutaneous Injection) as a single dose | Drug | Healthy Volunteer: Single Ascending Dose of Placebo |
Primary outcome
Incidence of adverse events
Time frame: Up to 71 days of monitoring
Incidence of abnormal laboratory test results
Time frame: Up to 71 days of monitoring
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
Time frame: Up to 71 days of monitoring
Incidence of treatment-emergent clinically abnormal physical exam
Time frame: Up to 71 days of monitoring
4 secondary outcomes
Plasma maximum measured drug concentration (Cmax)
Time frame: Up to 71 days of testing
Time of maximum concentration (Tmax)
Time frame: Up to 71 days of testing
Area under the concentration-time curve (AUC)
Time frame: Up to 71 days of testing
Plasma half-life (T½)
Time frame: Up to 71 days of testing
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 19 Jul 2022.
- Derived from this study: PubMed 38515275Novikov N, Buch A, Yang H, Andruk M, Liu G, Wu M, Howell H, MacDonald B, Savage W. First-in-Human Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of DISC-0974, an Anti-Hemojuvelin Antibody, in Healthy Participants. J Clin Pharmacol. 2024 Aug;64(8):953-962. doi: 10.1002/jcph.2432. Epub 2024 Mar 21.
- Related InfoLink provided by the sponsor.
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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.
William 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-0974 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 11 inclusion and 18 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 19 Jul 2022. 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. 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 71 days of monitoring). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999527, which also lists 1 linked publication.
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 19 Jul 2022.