Sickle Cell DiseasePhase 1NCT02998450
A Study of IMR-687 in Healthy Adult Volunteers
A Phase 1 study testing IMR-687 in people with Sickle Cell Disease and Sickle-Cell; Hb-SC, run by Cardurion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Sickle-Cell; Hb-SC, Sickle Beta 0 Thalassemia
- What is being tested?
- IMR-687
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to 8 Jul 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse.
Who cannot join
- Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive.
- Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers.
- A significant history of cardiovascular disease.
- On ECG, a QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator.
- Elevated blood pressure.
- Use within 30 days prior to Day 1 of any inhibitors or substrates of targets of IMR-687.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a Study of IMR-687 in Healthy Adult Volunteers
The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.
- Being tested
- IMR-687, Placebo Oral Capsule
- Keywords
- Sickle Cell Disease, Sickle Beta 0 Thalassemia
- Medical subject headings
- Anemia, Sickle Cell, Hemoglobin SC Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMR-687Drug
1 of 6 possible single doses administered orally following overnight fast
Placebo Oral CapsuleDrug
Also called Microcrystalline cellulose
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. Receives: Drug: IMR-687; Drug: Placebo Oral Capsule |
| Cohort 2 | Experimental | 4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. Receives: Drug: IMR-687; Drug: Placebo Oral Capsule |
| Cohort 3 | Experimental | 4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. Receives: Drug: IMR-687; Drug: Placebo Oral Capsule |
| Cohort 4 | Experimental | 4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. Receives: Drug: IMR-687; Drug: Placebo Oral Capsule |
| Cohort 5 | Experimental | 4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. Receives: Drug: IMR-687; Drug: Placebo Oral Capsule |
| Cohort 6 | Experimental | 4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. Receives: Drug: IMR-687; Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events and serious adverse events
Measured: 5 Days
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Measured: Baseline to Day 5
Number of participants with clinically significant changes from baseline in physical examination
Measured: Baseline to Day 5
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
Measured: Baseline to Day 5
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
Measured: Baseline to Day 2
Use of concomitant medications and therapies, medication type and frequency
Measured: 5 Days
Secondary outcomes (7)
Pharmacokinetics (PK) of IMR-687
Maximum Observed Plasma Concentration (Cmax) of IMR-687
Measured: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Area under the curve (AUC) ( 0 to 24 h) of IMR-687
Measured: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
AUC from time 0 to the last measurable time point (AUClast) of IMR-687
Measured: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
AUC extrapolated to infinity (AUC0 ∞) of IMR-687
Measured: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time to maximum concentration (tmax) of IMR-687
Measured: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Apparent terminal half-life (t½) of IMR-687
Measured: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
The change from baseline in QTcF interval.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start18 Oct 2016
- Primary completion8 Jul 2017
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Imara, Inc.
- Responsible party
- Sponsor
- Investigators
- Regulatory Operations, Study director, Cardurion Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998450
- Sponsor's protocol ID
- IMR-SCD-101
- Status last verified
- May 2025
- First submitted
- 6 Dec 2016
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a Study of IMR-687 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02998450
- Acronym / sponsor ID
- IMR-SCD-101
- Keywords
- Sickle Cell Disease, Sickle Beta 0 Thalassemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Imara, Inc.
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 8 Jul 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: IMR-687, Drug: Placebo Oral Capsule4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
| Cohort 2 | Experimental | Drug: IMR-687, Drug: Placebo Oral Capsule4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
| Cohort 3 | Experimental | Drug: IMR-687, Drug: Placebo Oral Capsule4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
| Cohort 4 | Experimental | Drug: IMR-687, Drug: Placebo Oral Capsule4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
| Cohort 5 | Experimental | Drug: IMR-687, Drug: Placebo Oral Capsule4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
| Cohort 6 | Experimental | Drug: IMR-687, Drug: Placebo Oral Capsule4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse.
Key exclusion criteria (6 listed)
- Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive.
- Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers.
- A significant history of cardiovascular disease.
- On ECG, a QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator.
- Elevated blood pressure.
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 |
|---|---|---|
| IMR-6871 of 6 possible single doses administered orally following overnight fast | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| Placebo Oral CapsuleAlso: Microcrystalline cellulosePlacebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Number of participants with treatment emergent adverse events and serious adverse events
Time frame: 5 Days
Number of participants with clinically significant changes from baseline in vital signs
Time frame: Baseline to Day 5
Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Number of participants with clinically significant changes from baseline in physical examination
Time frame: Baseline to Day 5
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
Time frame: Baseline to Day 5
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
Time frame: Baseline to Day 2
Use of concomitant medications and therapies, medication type and frequency
Time frame: 5 Days
7 secondary outcomes
Pharmacokinetics (PK) of IMR-687
Time frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
The change from baseline in QTcF interval.
Time frame: 2 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 15 May 2025.
- Individual participant dataSharing planned: No
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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.
Regulatory Operations study director
Cardurion Pharmaceuticals
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 IMR-687 in people with Sickle Cell Disease and Sickle-Cell; Hb-SC, run by Cardurion Pharmaceuticals, 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 1 inclusion and 6 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 15 May 2025. 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?
Number of participants with treatment emergent adverse events and serious adverse events (time frame: 5 Days). The study lists 6 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 15 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.